Compositions and methods for treating an infection

ABSTRACT

A method of treating or preventing a bacterial infection of a subject may include combining levofloxacin and a diluent to form a treatment solution and topically administering the treatment solution to the subject to bath a skin area with the treatment solution. The treatment solution may include levofloxacin oral solution.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation in-part application and claimsthe benefit of the filing date under 35 U.S.C. § 120 of co-pending U.S.patent application Ser. No. 15/625,989, entitled Compositions andMethods for Treating an Infection, filed Jun. 16, 2017. U.S. U.S. patentapplication Ser. No. 15/625,989 is a continuation-in-part and claims thebenefit of the filing dates under 35 U.S.C. § 120 of U.S. patentapplication Ser. No. 14/975,172 (now U.S. Pat. No. 9,707,229), entitledCompositions and Methods for Treating an Infection, filed Dec. 18, 2015,and U.S. patent application Ser. No. 15/440,800, entitled Compositionsand Methods for Treating an Infection, filed Feb. 23, 2017. U.S. patentapplication Ser. No. 15/440,800 claims priority under 35 U.S.C. § 119(e)to U.S. Provisional Patent Application No. 62/298,991, filed 23 Feb.2016 and U.S. Provisional Patent Application No. 62/289,994, filed 23Feb. 2016. U.S. Provisional Patent Application No. 62/298,991, and U.S.Provisional Patent Application No. 62/289,994 are hereby incorporated byreference in their entirety.

FIELD OF THE INVENTION

The present application relates to compounded compositions, methods ofmaking compounded compositions, and methods of using compoundedcompositions to treat or prevent an infection. The present applicationalso relates to anti-infective agents and methods of usinganti-infective agents to treat or prevent an infection.

BACKGROUND

The body normally serves as host for a variety of bacteria and fungi.Most of the time, the balance between the body as host and themicroorganisms is maintained. However, there are times when thephysiological, biochemical, and/or environmental conditions permit themicroorganisms to tip that balance, thereby causing an infection.

Foot infections can be difficult problems for physicians to treatbecause of the biomechanical complexities of the extremity and theunderlying circumstances that cause the infections. Soft tissueinfections in the foot consist of any infectious process affecting theskin, subcutaneous tissue, adipose tissue, superficial or deep fascia,ligaments, tendons, tendon sheaths, joints, and/or joint capsules.Considering that there are more than 20 joints, 44 tendons,approximately 100 ligaments, 4 major compartments, and numerous fascialplanes in the normal foot, the potential for complex problems is high.

Bacterial infections of the feet can occur as collections of pus, suchas an abscess following a puncture wound or an infected hair follicle.These types of infections are usually red and elevated, and sometimescan be mistaken for an insect bite. There are many types of bacteriathat cause an abscess, but staph are a leading cause. Bacterial skininfections can also resemble a rash, appearing as a reddened, tender,and warm area of skin. This type of infection is called cellulitis andcan spread quickly, leading to red streaks that move from the foottoward the leg. The appearance of streaks is known as lymphangitis,which means the infection is spreading toward the lymph nodes.Cellulitis and lymphangitis can be caused by a variety of types ofbacteria, but staph and sometimes streptococcus are the most commoncauses. Any infection, especially cellulitis and lymphangitis, requiresprompt medical attention to avoid further spreading and complications.If left untreated, then some infections can spread to deeper tissues,including bone.

Certain fungal infections of the skin known as tinea infections arecaused by dermatophytes, which are members of the Trichophyton,Microsporum, and Epidermophyton species. These mold-like fungi thrive inwarm, moist areas, thriving on the dead tissues of hair, nails, andouter skin layers. Tinea infections include tinea pedis, known asathlete's foot; tinea corporis, known as ringworm; tinea capitis, afungal infection of the scalp that can cause hair loss; tinea cruris,known as jock itch or tinea of the groin; tinea unguum, which is tineaof the nails; and tinea versicolor, a superficial fungal infection thatproduces brown, tan, or white spots on the trunk of the body. Tineainfections are contagious and can be passed through direct contact or bycontact with clothing, from shower and pool surfaces, and even frompets.

Athlete's foot or tinea pedis is by far the most common form, with morethan 12 million people in the United States suffering from the diseaseper year. It presents with redness, itching, burning, cracking, scaling,swelling, and occasionally bleeding. Athlete's foot includes toe webinfections, moccasin type infections, and vesicular type infections. Thecondition generally includes small vesicles, fissures, scaling,maceration, hyperkeratinization, and eroded areas between the toes andon the plantar surface of the foot, as well as on other skin areas. Forexample, the nails may show thickening, pitting, and subungal debris.

Reoccurrences of the infection are frequent. For some subjects, such asthose also diagnosed with diabetes or circulatory problems, or obesesubjects, tinea infections and their treatment can be quite serious. Thesource of the affliction often is a public safety and health concern, asthe occurrence of tinea pedis is higher in public areas such as lockerrooms, public showers, sports facilities, and the like.

Moreover, there are at least 3 different types of nail infections causedby fungi. The most common infection is frequently caused by Trichophytonrubrum and affects the nail bed and the area beneath the nail. Anothertype of infection affects only the nail surface and creates white orlight colored patches. This second type of fungal infection is unusualand represents only about 10% of the reported cases. A third type offungal infection affects the nail root and usually afflicts persons withimpaired immune defense. A fourth (and unusual) type is caused by aninfection of yeast fungi. Infections by yeast most often only affectnails that already are infected or damaged in some way.

The fungi are invasive to the keratin nail tissue. Apart from becomingdiscolored and brittle, the nail may often separate from the nail bed.In addition, pain and difficulty in wearing foot apparel is oftenexperienced. Initially, the disease affects only one nail, typically onenail of the foot, and is thereafter spread to more nails. The palms ofthe hands and the soles of the feet may frequently be affected as well.When the skin is affected, red spots frequently occur and the skin maypeel off. Nail fungal infections are one of the hardest forms ofexternal infection to treat, of which infections of toe nails are themost difficult to treat.

Despite advances in the understanding of the pathology of bacterialinfections and fungal infections, there is still a need for compositionsand methods that efficiently treat or prevent the progression andreoccurrence of bacterial infections and/or fungal infections thataffect at least part of one or both feet.

SUMMARY

In one aspect, a method of treating or preventing a bacterial infectionof a subject includes combining levofloxacin and a diluent to form atreatment solution. The treatment solution may be topically administeredto an outer surface of the subject to contact, e.g., bathe, the areawith the treatment solution.

In various embodiments, combining the levofloxacin and diluent includes(a) combining levofloxacin oral solution, 125 mg/5 mL (25 mg/mL), andthe diluent; (b) combining about 10 mL to about 30 mL levofloxacin oralsolution, 125 mg/5 mL (25 mg/mL), and the diluent; or (c) combiningabout 10 mL to about 30 mL levofloxacin oral solution, 125 mg/5 mL (25mg/mL), and at least 20 mL of diluent.

In one embodiment, combining the levofloxacin and the diluent includescombining about 10 mL to about 30 mL levofloxacin oral solution, 125mg/5 mL (25 mg/mL), and about 1 L to about 2 L of diluent. The outerbody surface may include all or a portion of a foot or hand. Contactingmay include submerging the area in a bath of the treatment solutionwithin a bathing container. The diluent may include sterile water,sodium hypochlorite, or Dakin's solution. In one embodiment, the methodincludes agitating the treatment solution within the bathing containerduring administration.

In another aspect, a system for treating or preventing a bacterialinfection of a subject includes a treatment solution comprising adiluent and levofloxacin oral solution, 125 mg/5 mL (25 mg/mL), and abathing container to contain the treatment solution for topicallyadministering the treatment solution to an outer body surface, such as askin area, of the subject.

In various embodiments, the treatment solution may include levofloxacinoral solution, 25 mg/mL, and the diluent; about 10 mL to about 30 mLlevofloxacin oral solution, 125 mg/5 mL (25 mg/mL), and at least 20 mLof diluent; or about 10 mL to about 30 mL levofloxacin oral solution,125 mg/5 mL (25 mg/mL), and about 1 L to about 2 L of diluent. Thediluent may include sterile water. In some embodiments, the diluent mayinclude sodium hypochlorite or Dakin's solution.

In various embodiments, the outer body surface includes all or a portionof a foot, hand, or other appendage. The bathing container may beconfigured to receive at least a portion of the hand, foot, or otherappendage of the subject to topically bathe the area with the treatmentsolution within the bathing container. In one embodiment, the system mayfurther include an agitator or agitator agent to agitate the treatmentsolution within the bathing container.

In another aspect, a method of topically treating or preventing abacterial infection of a subject includes topically administering atreatment solution comprising levofloxacin oral solution, 125 mg/5 mL(25 mg/mL), to a subject, wherein topically administering comprisescontacting skin or underlying exteriorly exposed tissue from an exteriorside of the subject with the treatment solution. In various embodiments,the treatment solution is administered utilizing a bath, irrigation, orspray application. In one example, the treatment solution comprisesabout 10 mL to about 30 mL levofloxacin oral solution, 125 mg/5 mL (25mg/mL), and at least 20 mL of diluent.

DESCRIPTION

The present invention can be understood more readily by reference to thefollowing detailed description of the invention and the Examplesincluded therein.

Before the present compounds, compositions, articles, systems, devices,and/or methods are disclosed and described, it is to be understood thatthey are not limited to specific synthetic methods unless otherwisespecified, or to particular reagents unless otherwise specified, as suchmay, of course, vary. It is also to be understood that the terminologyused herein is for the purpose of describing particular aspects only andis not intended to be limiting. Although any methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present invention, example methods andmaterials are now described.

All publications mentioned herein are incorporated herein by referenceto disclose and describe the methods and/or materials in connection withwhich the publications are cited. The publications discussed herein areprovided solely for their disclosure prior to the filing date of thepresent application. Nothing herein is to be construed as an admissionthat the present invention is not entitled to antedate such publicationby virtue of prior invention.

A. Definitions

As used in the specification and the appended claims, the singular forms“a”, “an”, and “the” include plural referents unless the context clearlydictates otherwise.

The phrase “consisting essentially of limits the scope of a claim to therecited components in a composition or the recited steps in a method aswell as those that do not materially affect the basic and novelcharacteristic or characteristics of the claimed composition or claimedmethod. The phrase “consisting of excludes any component, step, orelement that is not recited in the claim. The phrase “comprising” issynonymous with “including”, “containing”, or “characterized by”, and isinclusive or open-ended. “Comprising” does not exclude additional,unrecited components or steps.

As used herein when referring to any numerical value, the term “about”means a value falling within a range that is ±10% of the stated value.

Ranges can be expressed herein as from “about” one particular value,and/or to “about” another particular value. When such a range isexpressed, a further aspect includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms a further aspect. It willbe further understood that the endpoints of each of the ranges aresignificant both in relation to the other endpoint and independently ofthe other endpoint. It is also understood that there are a number ofvalues disclosed herein, and that each value is also herein disclosed as“about” that particular value in addition to the value itself. Forexample, if the value “10” is disclosed, then “about 10” is alsodisclosed. It is also understood that each unit between two particularunits are also disclosed. For example, if 10 and 15 are disclosed, then11, 12, 13, and 14 are also disclosed.

References in the specification and concluding claims to parts by weightof a particular element or component in a composition denotes the weightrelationship between the element or component and any other elements orcomponents in the composition or article for which a part by weight isexpressed. Thus, in a compound containing 2 parts by weight of componentX and 5 parts by weight component Y, X and Y are present at a weightratio of 2:5, and are present in such ratio regardless of whetheradditional components are contained in the compound.

As used herein, the terms “optional” or “optionally” means that thesubsequently described event or circumstance can or cannot occur, andthat the description includes instances where said event or circumstanceoccurs and instances where it does not. For example, in an aspect, adisclosed method can optionally comprise one or more additional steps,such as, for example, repeating an administering step or altering anadministering step.

As used herein, the term “capsule” includes a soft or hard shellcapsule. A capsule shell can be a unibody delivery vehicle or can becomprised of two capsule shell pieces. In an aspect, the longer capsuleshell piece can be called the “body” and the smaller capsule shell piececan be called the “cap”. The body and the cap can engage with each otheras one shell body. As known to the art, capsule sizes can differconsidering various factors that are tailored for any particularapplication, such as dosage amount or route of administration. Capsulescan be manufactured to achieve a variety of capsule shell thicknesses.The release characteristics of a capsule can vary depending on thecapsule shell thickness and composition. Standard capsule sizes areknown in the art, and include, but are not limited to, the followingsizes: Su07 (−28 mL), 7 (−24 mL), 10 (−18 mL), 11 (−10 mL), 12e1 (−7.5mL), 12 (−5 mL), 13 (−3.2 mL), 000 (−1.37 mL), 00 (−0.95 mL), 0 (−0.68mL), 1 (−0.50 mL), 2 (−0.37 mL), 3 (−0.30 mL), 4 (−0.21 mL), and 5(−0.13 mL). Actual volumes in mL are shown in parenthesis. Capsules fororal administration typically range from a size 5 (volume of 0.1 mL)capsule to a size 000 (volume of 1.37 mL) capsule. The capacity of acapsule measures how much of a disclosed compounded composition or adisclosed agent that a capsule can hold or contain. The capacity of acapsule depends largely on the density of the composition (compositionsand anti-infective agents vary widely in density). A capsule can holdless of a composition or an anti-infective agent with a low density(i.e., around 0.6 g/mL) and can hold more of a composition or an agenthaving a high density (i.e., 1.2 g/mL). The table below shows theapproximate capacity (in milligrams) of various capsules (e.g., capsulesize 000 to capsule size 4) across a range of densities for a disclosedcompounded composition or a disclosed anti-infective agent (i.e., ananti-bacterial agent or an anti-fungal agent).

Capacity (mg) for Various Capsule Sizes Powder Density 000 00 0 1 2 3 40.6 g/ml 822 570 408 288 216 162 120 0.8 g/ml 1096 760 544 384 288 216160 1.0 g/ml 1370 950 680 480 360 270 200 1.2 g/ml 1644 1140 816 576 432324 240

As used herein, the term “subject” refers to the target ofadministration, e.g., an animal. The term “subject” also includesdomesticated animals (e.g., cats, dogs, etc.), livestock (e.g., cattle,horses, pigs, sheep, goats, etc.), and laboratory animals (e.g., mouse,rabbit, rat, guinea pig, fruit fly, etc.). Thus, the subject of theherein disclosed methods can be a vertebrate, such as a mammal, a fish,a bird, a reptile, or an amphibian. Alternatively, the subject of theherein disclosed methods can be a human, non-human primate, horse, pig,rabbit, dog, sheep, goat, cow, cat, guinea pig, or rodent. The term doesnot denote a particular age or sex. Thus, adult and newborn subjects, aswell as fetuses, whether male or female, are intended to be covered. Inan aspect, a subject can be a human patient. A subject can havediabetes. A subject can be obese. A subject can have circulatory issues.A subject can have a bacterial infection, be suspected of having abacterial infection, or be at risk of developing a bacterial infection.A subject can have a fungal infection, be suspected of having a fungalinfection, or be at risk of developing a fungal infection. For example,a subject can have damaged or moist skin, can have chronic disease, orcan be immunocompromised. A subject can have a bacterial infection and afungal infection, be suspected of having a bacterial infection and afungal infection, or be at risk of developing a bacterial infection anda fungal infection.

For example, a subject at risk of developing a bacterial infection canhave, for example, risk factors for developing a bacterial infection(e.g., have damaged or moist skin, have chronic disease, and/or beimmunocompromised). For example, a subject at risk for developing abacterial infection can be exposed to a bacterium or bacteria due toemployment (e.g., a health care worker) or due to the prevalence of abacterium or bacteria at a specific location (e.g., a hospital).

For example, a subject at risk of developing a fungal infection canhave, for example, risk factors for developing a fungal infection (e.g.,have damaged or moist skin, have chronic disease, and/or beimmunocompromised). For example, a subject at risk for developing afungal infection can be exposed to a fungus or fungi due to employment(e.g., a health care worker) or due to the prevalence of a fungus orfungi at a specific location (e.g., a hospital).

A “patient” refers to a subject afflicted with one or more diseases ordisorders. In an aspect, a patient can refer to a subject that has beendiagnosed with or is suspected of having a fungal infection. In anaspect, a patient can refer to a subject that has been diagnosed with oris suspected of having a bacterial infection. In an aspect, a bacterialinfection or suspected bacterial infection can affect at least a portionof one or both feet of the subject. In an aspect, a bacterial infectionor suspected bacterial infection can affect another appendage, such asat least a portion of one or both of the subject's hands. In an aspect,a fungal infection or suspected fungal infection can affect at least aportion of one or both feet of the subject. In an aspect, a fungalinfection or suspected fungal infection can affect another appendage,such as at least a portion of one or both of the subject's hands.

As used herein, the term “treatment” refers to the medical management ofa patient with the intent to cure, ameliorate, stabilize, or prevent adisease, pathological condition, or disorder (such as, for example, abacterial infection, a suspected bacterial infection, a fungalinfection, or a suspected fungal infection, or both). This term includesactive treatment, that is, treatment directed specifically toward theimprovement of a disease, pathological condition, or disorder, and alsoincludes causal treatment, that is, treatment directed toward removal ofthe cause of the associated disease, pathological condition, ordisorder. In addition, this term includes palliative treatment, that is,treatment designed for the relief of symptoms rather than the curing ofthe disease, pathological condition, or disorder; preventativetreatment, that is, treatment directed to minimizing or partially orcompletely inhibiting the development of the associated disease,pathological condition, or disorder; and supportive treatment, that is,treatment employed to supplement another specific therapy directedtoward the improvement of the associated disease, pathologicalcondition, or disorder. In various aspects, the term covers anytreatment of a subject, including a mammal (e.g., a human), andincludes: (i) preventing the disease from occurring in a subject thatcan be predisposed to the disease but has not yet been diagnosed ashaving it; (ii) inhibiting the disease, i.e., arresting its development;or (iii) relieving the disease, i.e., causing regression of the disease.

In an aspect, “treating” means eradicating a bacterial infection, afungal infection, a suspected bacterial infection, a suspected fungalinfection, or a combination thereof. In an aspect, “treating” meansreducing the effects of a bacterial infection or fungal infection orsymptoms of a bacterial infection or a fungal infection. Thus, in anaspect of a disclosed method, treating can refer to a 10%, 20%, 30%,40%, 50%, 60%, 70%, 80%, 90%, or 100% reduction in the severity of anestablished bacterial infection or an established fungal infection or inthe symptoms of a bacterial infection or a fungal infection. Forexample, a method for treating a bacterial infection or fungal infectioncan reduce one or more symptoms of a bacterial infection, a fungalinfection, or both in a subject by 10% as compared to a control. In anaspect, a reduction of one or more symptoms can be 20%, 30%, 40%, 50%,60%, 70%, 80%, 90%, 100%, or any percent reduction in between 10% and100% as compared to a control. It is understood that treatment does notnecessarily refer to a cure or complete ablation or eradication of thebacterial infection or the fungal infection, or both. However, in anaspect, treatment can refer to a cure or complete ablation oreradication of the bacterial infection, the fungal infection, or both.

As used herein, the term “prevent” or “preventing” refers to precluding,averting, obviating, forestalling, stopping, or hindering something fromhappening, especially by advance action. It is understood that wherereduce, inhibit or prevent are used herein, unless specificallyindicated otherwise, the use of the other two words is also expresslydisclosed. In an aspect, preventing a bacterial infection, fungalinfection, or both is intended.

As used herein, the term “diagnosed” means having been subjected to aphysical examination by a person of skill, for example, a physician, andfound to have a condition that can be diagnosed or treated by thecompounds, compositions, agents, or methods disclosed herein. Forexample, “diagnosed with a bacterial infection” means having beensubjected to a physical examination by a person of skill, for example, aphysician, and found to have a condition that can be diagnosed or can betreated by a disclosed compound or composition or agent that can preventor inhibit a bacterial infection. For example, “suspected of having abacterial infection” can mean having been subjected to a physicalexamination by a person of skill, for example, a physician, and found tohave a condition that can be likely be diagnosed as or can likely betreated by a disclosed compound or composition or agent that can preventor inhibit a bacterial infection, or it can mean that the subjectbelieves that he or she has a bacterial infection. For example,“diagnosed with a fungal infection” means having been subjected to aphysical examination by a person of skill, for example, a physician, andfound to have a condition that can be diagnosed or can be treated by adisclosed compound or composition or agent that can prevent or inhibit afungal infection. For example, “suspected of having a fungal infection”can mean having been subjected to a physical examination by a person ofskill, for example, a physician, and found to have a condition that canbe likely be diagnosed as or can likely be treated by a disclosedcompound or composition or agent that can prevent or inhibit a fungalinfection, or it can mean that the subject believes that he or she has afungal infection.

As used herein, the terms “administering” and “administration” refer toany method of providing a disclosed composition, compounded composition,anti-infective agent, or a pharmaceutical preparation to a subject. Suchmethods are well known to those skilled in the art and include, but arenot limited to: oral administration, transdermal administration,administration by inhalation, nasal administration, topicaladministration, intravaginal administration, ophthalmic administration,intraaural administration, intracerebral administration, rectaladministration, sublingual administration, buccal administration, andparenteral administration, including injectable such as intravenousadministration, intra-arterial administration, intramuscularadministration, and subcutaneous administration. Administration can becontinuous or intermittent. In various aspects, a disclosed composition,compounded composition, or anti-infective agent can be administeredtherapeutically; that is, administered to treat an existing disease orcondition. In further various aspects, a disclosed composition,compounded composition, or anti-infective agent can be administeredprophylactically; that is, administered for prevention of a disease orcondition. In an aspect, the skilled person can determine an efficaciousdose, an efficacious schedule, and an efficacious route ofadministration for a disclosed composition, compounded composition, oranti-infective agent so as to treat a subject or inhibit or prevent aninflammatory reaction. In an aspect, the skilled person can also alter,change, or modify an aspect of an administering step so as to improveefficacy of a disclosed composition, compounded composition, oranti-infective agent. In an aspect, administering means contacting atleast a portion of one foot or both feet of a subject with agitatedwater comprising a disclosed composition, compounded composition, oranti-infective agent in a footbath.

As used herein, a “footbath” refers to a container that can hold somevolume (e.g., about 15 liters to about 30 liters) of aqueous solution(e.g., water) and is designed to physically accommodate at least aportion of one or both feet of a subject. Footbaths are known to theskilled person. A footbath can comprise several features or agents thateffect various functions. For example, a footbath can comprise one ormore lights or light-emitting devices, a mechanical agitation agent(e.g., one or more jets or bubble makers) to physically agitate theenclosed water, a bubble agent to create bubbles within the enclosedwater, a heating agent to heat the enclosed water, a vibration agent tovibrate the enclosed water (e.g., a high frequency vibration massage),an infrared device to provide infrared light to a foot or feet of thesubject, a massage agent (e.g., a roller) that provides massagingcontact to at least a portion of one or both feet, a pedicure agent thatcan clean or contact a foot or feet with a pumice, or a combinationthereof. In an aspect, an agitation agent or an agitator can be coupledto both a motor and the footbath. Motors and agitators are known to theart. In an aspect, a footbath can comprise one or more splash guards andother spill-resistant features to ensure that the water remains enclosedwithin a container. A footbath may also accommodate a subject's calves,meaning that the container is “deep” so as to allow the enclosed waterto contact both the feet and at least a portion of the calves of thesubject. Several manufacturers market footbaths including PIBB, Dr.Scholl's, Kendal, Conair, and Brookstone.

As used herein, a “scoop” refers to tool that can be used to measure ordispense a disclosed a compounded composition, a disclosed powder, or adisclosed anti-infective agent. In an aspect, a scoop can have apre-determined size that can measure a pre-determined amount. In anaspect, a scoop can measure or dispense an amount of about 1 g to about10 g. In an aspect, a scoop can measure about 1 g, about 2 g, about 3 g,about 4 g, about 5 g, about 6 g, about 7 g, about 8 g, about 9 g, orabout 10 g. In an aspect, a scoop can measure or dispense an amount of10 g or more. For example, in an aspect, a scoop can measure or dispensean amount of about 1 mg to about 1 g. In an aspect, a scoop can measureabout 1 mg, about 100 mg, about 200 mg, about 300 mg, about 400 mg,about 500 mg, about 600 mg, about 700 mg, about 800 mg, about 900 g, orabout 1 g. In an aspect, a scoop can measure or dispense an amount ofabout 250 mg. In an aspect, a scoop can measure or dispense an amount ofabout 500 mg. In an aspect, a scoop can measure or dispense an amount ofabout 1.5 g.

As used herein, a “scoop” can also refer to tool that can be used tomeasure or dispense a disclosed diluent. In an aspect, a scoop can havea pre-determined size that can measure a pre-determined volume. Forexample, in an aspect, a scoop can measure or dispense a volume of about1 mL to about 30 mL. In an aspect, a scoop can measure about 1 mL, about2 mL, about 3 mL, about 4 mL, about 5 mL, about 6 mL, about 7 mL, about8 mL, about 9 mL, about 10 mL, about 15 mL, about 20 mL, about 25 mL, orabout 30 mL. In an aspect, a scoop can measure or dispense an amount of10 mL or more. In an aspect, a scoop can measure or dispense an amountof about 15 mL.

As used herein, a “mixing container” can be a container that canaccommodate one more liquids (such as a diluent, for example) and one ormore disclosed compositions or disclosed anti-infective agents. A mixingcontainer can have a lid or a cover, which facilitates the mixing of anyliquid with any solid that has been added to the container. A mixingcontainer can be used to generate a solution. In an aspect, a mixingcontainer can contain an amount from about 2 ounces to about 30 ounces.In an aspect, a mixing container can contain an amount of about 6ounces. In an aspect, a mixing container can contain an amount of about16 ounces. The art is familiar with mixing containers and mixingcontainers are commercially available.

As used herein, “modifying the method” can comprise modifying orchanging one or more features or aspects of one or more steps of adisclosed method. For example, in an aspect, a method can be altered bychanging the amount of a disclosed compounded composition, a disclosedcomposition, or a disclosed anti-infective agent added to a footbath, bychanging the frequency of the subject's use of the footbath, or bychanging the duration of time that the subject's foot or feet contactthe water contained within the footbath, or a combination thereof.

As used herein, poloxamers are non-ionic poly (ethylene oxide)(PEO)-poly (propylene oxide) (PPO) copolymers. Poloxamers can be used inpharmaceutical formulations as surfactants, emulsifying agents,solubilizing agent, dispersing agents, and in vivo absorbance enhancer.Poloxamers are often considered as “functional excipients” because theyare essential components, and play an important role in the formulation.

The term “contacting” as used herein refers to bringing one or moredisclosed compositions, disclosed compounded compositions, or disclosedanti-infective agents together with water and an intended target (suchas at least a portion of one or both feet of a subject) or targeted area(such as an area diagnosed with, suspected of having a bacterialinfection or a fungal infection, or susceptible to developing abacterial infection or a fungal infection) in such a manner that thedisclosed composition, a disclosed compounded composition, or adisclosed anti-infective agent can exert an effect on the intendedtarget or targeted area either directly or indirectly. In an aspect,“contacting” means to insert or immerse at least a portion of one orboth feet of a subject into the water contained within a footbath.

The term “mixing” as used in a disclosed method of making a compoundedcomposition, for example, means to physically combine the recitedcomponents so as to achieve a homogenous compounded composition (whichcan be a dry powder formulation). For example, in an aspect, ananti-bacterial agent and an anti-fungal agent can be mixed with anexcipient base powder; that is, an anti-bacterial agent and ananti-fungal agent are physically combined with an excipient base powderand shaken, or stirred, or agitated so as to achieve a homogenouscompounded composition. In an aspect, multiple recited components can bemixed together (i.e., anti-bacterial agent, an anti-fungal agent, anexcipient base powder, and one or more additional anti-infective agents(i.e., anti-bacterial agent and anti-fungal agent). In an aspect,“mixing” can also include sifting the homogenous compounded compositionthough a fine mesh strainer. A suitable mixer is a TURBULA® mixer, whichis able to mix powdery substances with differing specific weights andparticle sizes. The mixing can be generally performed for apre-determined amount of time, i.e., for 10 seconds, 20 seconds, 30seconds, 45 seconds, 1 minute, 5 minute, 10 minutes, 20 minutes, 30minutes, 40 minutes, 50 minutes, 1 hour, 2 hours, 3 hours, or more. Aperson skilled in the art could ascertain without undue experimentation,the amount of time required to mix the recited components so as toachieve a homogenous compounded composition.

Also, in an aspect, “mixing” can be used to describe the process ofmaking a solution by adding one or more of a disclosed compoundedcomposition, a disclosed composition, or a disclosed anti-infectiveagent to a diluent. For example, mixing means to physically combine oneor more of a disclosed compounded composition, a disclosed composition,or a disclosed anti-infective agent with a diluent.

“Mixing” can occur in a disclosed mixing container. In an aspect, amixing container can have a pre-determined size that can measure or holda pre-determined amount or volume. For example, in an aspect, a mixingcontainer can measure or hold an amount of about 1 ounces to about 30ounces. In an aspect, mixing container can measure or hold about 1ounce, 2 ounces, 3 ounces, 4 ounces, 5 ounces, 6 ounces, 7 ounces, 8ounces, 9 ounces, 10 ounces, 11 ounces, 12 ounces, 13 ounces, 14 ounces,15 ounces, 16 ounces, 17 ounces, 18 ounces, 19 ounces, 20 ounces, 21ounces, 22 ounces, 23 ounces, 24 ounces, 25 ounces, 26 ounces, 27ounces, 28 ounces, 29 ounces, or 30 ounces. In an aspect, a mixingcontainer can measure or hold about 6 ounces. In an aspect, a mixingcontainer can measure or hold about 16 ounces.

As used herein, an anti-infective agent can be an anti-bacterial agent,an anti-fungal agent, a combination of anti-bacterial agents, acombination of anti-fungal agents, or a combination of anti-bacterialagents and anti-fungal agents.

Anti-bacterial agents are known to the art. For example, the artgenerally recognizes several categories of anti-bacterial agentsincluding (1) enicillins, (2) cephalosporins, (3) fluoroquinolones, (4)aminoglycosides, (5) monobactams, (6) carbapenems, (7) macrolides, and(8) other agents. For example, as used herein, an anti-bacterial agentcan comprise afenide, amikacin, amoxicillin, ampicillin, arsphenamine,azithromycin, azlocillin, aztreonam, bacampicillin, bacitracin,carbacephem (loracarbef), carbenicillin, cefaclor, cefadroxil,cefalotin, cefamandole, cefazolin, cefdinir, cefditoren, cefepime,cefixime, cefoperazone, cefotaxime, cefoxitin, cefpodoxime, cefprozil,ceftazidime, ceftibuten, ceftizoxime, ceftobiprole, ceftriaxone,cefuroxime, cephalexin, chloramphenicol, chlorhexidine, ciprofloxacin,clarithromycin, clavulanic acid, clindamycin, cloxacillin, colimycin,colistimethate teicoplanin, colistin, demeclocycline, dicloxacillin,dirithromycin, doripenem, doxycycline, efprozil, enoxacin, ertapenem,erythromycin, ethambutol, flucloxacillin, fosfomycin, furazolidone,gatifloxacin, geldanamycin, gentamicin, grepafloxacin, herbimycin,imipenem, isoniazid, kanamycin, levofloxacin, lincomycin, linezolid,lomefloxacin, meropenem, meticillin, meticillin, mezlocillin,minocycline, mitomycin, moxifloxacin, mupirocin, nafcillin, neomycin,netilmicin, nitrofurantoin, norfloxacin, ofloxacin, oxacillin,oxytetracycline, paromomycin, penicillin G, penicillin V, piperacillin,pivmecillinam, platensimycin, polymyxin B, prontosil, pvampicillin,pyrazinamide, quinupristin/dalfopristin, rifampicin, rifampin,roxithromycin, sparfloxacin, spectinomycin, spiramycin, sulbactam,sulfacetamide, sulfamethizole, sulfamethoxazole, sulfanilimide,sulfisoxazole, sulphonamides, sultamicillin, telithromycin,tetracycline, thiamphenicol, ticarcillin, tobramycin, trimethoprim,trimethoprim-sulfamethoxazole, troleandomycin, trovafloxacin, or acombination thereof.

Anti-fungal agents are known to the art. The art generally recognizesseveral categories of anti-fungal agents including (1) azoles(imidazoles), (2) antimetabolites, (3) allylamines, (4) morpholine, (5)glucan synthesis inhibitors (echinocandins), (6) polyenes, (7)benoxaaborale; (8) other antifungal/onychomycosis agents, and (9) newclasses of antifungal/onychomycosis agents. For example, as used herein,an anti-fungal agent can comprise abafungin, albaconazole, amorolfin,amphotericin b, anidulafungin, bifonazole, butenafine, butoconazole,candicidin, caspofungin, ciclopirox, clotrimazole, econazole,fenticonazole, filipin, fluconazole, flucytosine, griseofulvin,haloprogin, hamycin, isavuconazole, isoconazole, itraconazole,ketoconazole, micafungin, miconazole, naftifine, natamycin, nystatin,omoconazole, oxiconazole, polygodial, posaconazole, ravuconazole,rimocidin, sertaconazole, sulconazole, terbinafine, terconazole,tioconazole, tolnaftate, undecylenic acid, voriconazole, or acombination thereof.

Mupirocin is an anti-bacterial agent that has excellent activity againstgram-positive staphylococci and streptococci. Mupirocin is usedprimarily for the treatment of primary and secondary skin disorders,nasal infections, and wound healing. Mupirocin inhibits bacterialprotein synthesis by specific reversible binding to bacterial isoleucyltRNA synthase. The molecular formula for mupirocin is C₂₆H₄₄O₉.Azithromycin is a semi-synthetic macrolide antibiotic structurallyrelated to erythromycin. It has been used in the treatment ofMycobacterium avium intracellulare infections, toxoplasmosis, andcryptosporidiosis. The molecular formula for azithromycin isC₃₈H₇₂N₂O₁₂.

Itraconazole is a synthetic triazole antifungal agent that inhibitscytochrome P-450-dependent enzymes required for ergosterol synthesis.Itraconazole has antimycotic properties. Formulated for both topical andsystemic use, itraconazole preferentially inhibits fugal cytochrome P450enzymes, resulting in a decrease in fungal ergosterol synthesis. Becauseof its low toxicity profile, this agent can be used for long-termmaintenance treatment of chronic fungal infections. The molecularformula for itraconazole is C₃₅H₃₈Cl₂N₈O₄.

Fluconazole is a synthetic triazole with antifungal activity.Fluconazole preferentially inhibits fungal cytochrome P450 sterol C-14alpha-demethylation, resulting in the accumulation of fungal 14alpha-methyl sterols, the loss of normal fungal sterols, and fungistaticactivity. Mammalian cell demethylation is much less sensitive tofluconazole inhibition. The mechanism of action of fluconazole is as acytochrome P450 2C19 inhibitor, cytochrome P450 3A4 inhibitor, andcytochrome P450 2C9 inhibitor. The molecular formula for fluconazole isC₁₃H₁₂F₂N₆O.

Clindamycin Phosphate Topical Solution, or simply clindamycin solutionas used herein, is a commercially available clindamycin solution.Clindamycin Phosphate 1% topical solution contains clindamycinphosphate, USP, at a concentration equivalent to 10 mg clindamycin permilliliter. Clindamycin phosphate is a water soluble ester of thesemi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the7(R)-hydroxyl group of the parent antibiotic lincomycin. The solutioncontains isopropyl alcohol 39% w/v, propylene glycol, and purifiedwater. The solution may also contain sodium hydroxide for pH balance.

Erythromycin Topical Solution is a commercially available solution.Erythromycin 2% USP 2% contains erythromycin ((3R*,4S*,5S*,6R*,7R*,9R*,11R*,12R*,13S*,14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-0-methyl-a-L-ribo-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-64[3,4,6-trideoxy-3(dimethylamino)-0-D-xylohexopyranosyl]oxy]oxacyclotetradecane-2,10-dione), for topical dermatologic use.Erythromycin is a macrolide antibiotic produced from a strain ofSaccaropolyspora erythraea (formerly Streptomyces erythreus). It is abase and readily forms salts with acids.

Levofloxacin is a synthetic antibacterial agent with the empiricalformula C₁₈H₂₀FN₃O₄.½H₂O and a molecular weight of 370.38. Levofloxacinis commercially available in a bulk powder format as well as in capsule,oral solution, and injection dosage formulations. Levofloxacin iscurrently administered orally in tablet and oral solution dosage forms.Levofloxacin tablets are commercially available in various strengthsincluding in 200 mg, 500 mg, and 750 mg tablets. Levofloxacin oralsolution is commercially available in the United States in 25 mg/mLstrength formulations. Such oral solutions also include inactives suchas vehicles, solvents, stabilizers, coloring agents, or flavoringagents. In one example, levofloxacin oral solution contains, in additionto levofloxacin, artificial and natural flavors, ascorbic acid, benzylalcohol, caramel color, glycerin, hydrochloric acid, propylene glycol,purified water, sucralose and sucrose. As another example, levofloxacinoral solution contains the following inactive ingredients: artificialbubble gum flavor, artificial grape flavor, ascorbic acid, benzylalcohol, glycerin, hydrochloric acid, PFC Bitter Mask F9885, propyleneglycol, purified water, saccharin sodium, and sucrose. Sodium hydroxidemay be used to adjust pH (between approximately 5.0 to approximately6.0). Levofloxacin is also currently administered parenterally viaintravenous injection. Levofloxacin for injection is commerciallyavailable in various strengths and volumes. For example, levofloxacinfor injection is currently available in 500 mg/20 mL strength, 20 mLvolume single use container, and in 250 mg/50 mL strength, 50 mL, 100mL, and 150 mL single-use containers.

Linezolid is an antibacterial agent with the empirical formulaC₁₆H₂₀FN₃O₄ and a molecular weight of 337.35. Linezolid is commerciallyavailable in a bulk powder format as well as in granules for oralsuspension, oral solution, injection dosage, and oral tabletformulations.

Linezolid for oral suspension may be supplied as a flavored, e.g.,orange-flavored, granule/powder for constitution into a suspension fororal administration. Depending on the strength and constitution ratio,following constitution, each 5 mL typically contains about 100 mg oflinezolid. Inactive ingredients may include sucrose, citric acid, sodiumcitrate, microcrystalline cellulose and carboxymethylcellulose sodium,aspartame, xanthan gum, mannitol, sodium benzoate, colloidal silicondioxide, sodium chloride, and flavors. Sodium (Na+) content may be about8.52 mg per 5 mL (0.4 mEq per 5 mL). For example, Zyvox oral suspensionis a white, fluid which is orange flavoured. It is supplied in an amberglass bottle with a screw cap. Zyvox oral suspension may contain 20 mgof linezolid per 1 mL (total 150 mL), sucrose, mannitol,microcrystalline cellulose, carmellose sodium, aspartame, anhydrouscolloidal silica, sodium citrate, xanthan gum, sodium benzoate, citricacid anhydrous, and sodium chloride. The granules may be flavoured withMafco magnasweet, orange flavour, orange cream flavour, Sweet-am powder,vanilla flavour and peppermint flavour.

Linezolid injection may be supplied as a ready-to-use sterile isotonicsolution for intravenous infusion. For example, each container maycontain 600 mg of linezolid in 300 mL of a clear, colorless to slightlyyellow aqueous solution. Inactive ingredients may include: citric acidanhydrous USP 1.92 mg/mL, sodium chloride USP 9 mg/mL, sodium hydroxideNF 0.76 mg/mL, and water for injection USP. Sodium hydroxide NF and/orhydrochloric acid NF are typically used to adjust the pH. The sodium(Na+) content may be about 3.98 mg/mL (52 mEq/300-mL container). Zyvoxfor injection is supplied as a ready-to-use sterile isotonic solutionfor intravenous infusion. Each mL contains 2 mg of linezolid. Inactiveingredients are sodium citrate, citric acid, and dextrose in an aqueousvehicle for intravenous administration. The sodium (Na+) content isabout 0.38 mg/mL (5 mEq per 300-mL bag; 3.3 mEq per 200-mL bag; and 1.7mEq per 100-mL bag).

Linezolid tablets for oral administration are currently available underthe tradename Zyvox in 400 mg or 600 mg linezolid as film-coatedcompressed tablets. Inactive ingredients may include corn starch,microcrystalline cellulose, hydroxypropylcellulose, sodium starchglycolate, magnesium stearate, hypromellose, polyethylene glycol,titanium dioxide, and carnauba wax. The sodium (Na+) content may beabout 1.95 mg per 400 mg tablet and about 2.92 mg per 600 mg tablet(which may be 0.1 mEq per tablet, regardless of strength). Similarlinezolid generic tablets are also available. For example, linezolid 600mg tablets are currently manufactured for TEVA Pharmaceuticals USA,Inc., North Wales, Pa. 19454, which include the inactive ingredientscroscarmellose sodium, crospovidone, hypromellose, magnesium stearate,maize starch, mannitol, polyethylene glycol, povidone, and titaniumdioxide. The sodium (Na+) content is about 4.3 mg (0.2 mEq) per 600 mgtablet. The FDA has approved the following manufactures for commercialmarketing of linezolid tablets, 600 mg, Gate Pharmaceuticals, GlenmarkPharmaceuticals, Hetro Labs LTD Unit V, Mylan Pharmaceuticals Inc.,Novel Laboratories Inc., and Zydus Pharmaceuticals USA Inc.

The term “pharmaceutically acceptable” describes a material that is notbiologically or otherwise undesirable, i.e., without causing anunacceptable level of undesirable biological effects or interacting in adeleterious manner. The term “pharmaceutically acceptable salts”describes salts of active pharmaceuticals. It is to be appreciated thatrecitations herein of a particular active pharmaceuticals is to includepharmaceutically acceptable salts thereof whether or not specificallyrecited as such. As used herein, the term “pharmaceutically acceptablecarrier” refers to sterile aqueous or nonaqueous solutions, dispersions,suspensions or emulsions, as well as sterile powders for reconstitutioninto sterile injectable solutions or dispersions just prior to use.Examples of suitable aqueous and nonaqueous carriers, diluents, solventsor vehicles include water, ethanol, polyols (such as glycerol, propyleneglycol, polyethylene glycol and the like), carboxymethylcellulose andsuitable mixtures thereof, vegetable oils (such as olive oil) andinjectable organic esters such as ethyl oleate. These compositions canalso contain adjuvants such as preservatives, wetting agents,emulsifying agents and dispersing agents. Prevention of the action ofmicroorganisms can be ensured by the inclusion of various anti-bacterialand anti-fungal agents such as paraben, chlorobutanol, phenol, sorbicacid and the like. It can also be desirable to include isotonic agentssuch as sugars, sodium chloride and the like. Prolonged absorption ofthe injectable pharmaceutical form can be brought about by the inclusionof agents, such as aluminum monostearate and gelatin, which delayabsorption. Injectable depot forms are made by forming microencapsulematrices of the drug in biodegradable polymers such aspolylactide-polyglycolide, poly(orthoesters) and poly(anhydrides).Depending upon the ratio of drug to polymer and the nature of theparticular polymer employed, the rate of drug release can be controlled.Depot injectable formulations are also prepared by entrapping the drugin liposomes or microemulsions which are compatible with body tissues.The injectable formulations can be sterilized, for example, byfiltration through a bacterial-retaining filter or by incorporatingsterilizing agents in the form of sterile solid compositions which canbe dissolved or dispersed in sterile water or other sterile injectablemedia just prior to use. Suitable inert carriers can include sugars suchas lactose.

As used herein, “determining” can refer to measuring or ascertaining thepresence and severity of an infection, such as, for example, a bacterialinfection or a fungal infection that affects one or more of a subject'sappendages (e.g., at least a portion of one or both feet). Methods andtechniques used to determining the presence and/or severity of aninfection are typically known to the medical arts. For example, the artis familiar with the ways to identify and/or diagnose the presence,severity, or both of a bacterial infection, a fungal infection, or both.

As used herein, “effective amount” and “amount effective” can refer toan amount that is sufficient to achieve the desired result such as, forexample, the treatment and/or prevention of a bacterial infection or asuspected bacterial infection or a fungal infection or a suspectedfungal infection. As used herein, the terms “effective amount” and“amount effective” can refer to an amount that is sufficient to achievethe desired an effect on an undesired condition (e.g., a bacterial orfungal infection). For example, a “therapeutically effective amount”refers to an amount that is sufficient to achieve the desiredtherapeutic result or to have an effect on undesired symptoms, but isgenerally insufficient to cause adverse side effects. The specifictherapeutically effective dose level for any particular patient willdepend upon a variety of factors including the disorder being treatedand the severity of the disorder; the specific composition employed; theage, body weight, general health, sex and diet of the patient; the timeof administration; the route of administration; the rate of excretion ofthe specific compound employed; the duration of the treatment; drugsused in combination or coincidental with the specific compound employedand like factors well known in the medical arts. For example, it is wellwithin the skill of the art to start doses of a compound at levels lowerthan those required to achieve the desired therapeutic effect and togradually increase the dosage until the desired effect is achieved. Ifdesired, then the effective daily dose can be divided into multipledoses for purposes of administration. Consequently, single dosecompositions can contain such amounts or submultiples thereof to make upthe daily dose. The dosage can be adjusted by the individual physicianin the event of any contraindications. Dosage can vary, and can beadministered in one or more dose administrations daily, for one orseveral days. Guidance can be found in the literature for appropriatedosages for given classes of pharmaceutical products. In further variousaspects, a preparation can be administered in a “prophylacticallyeffective amount”; that is, an amount effective for prevention of adisease or condition, such as, for example, a bacterial infection or afungal infection.

As used herein, LoxaSperse™ refers to an excipient base powdercomprising a blend of micronized xylitol and poloxamers. LoxaSperse™ isused as a chemical dispersing or solubilizing agent, thereby improvingthe solubility and dispersibility of poorly water soluble activepharmaceutical ingredients (APIs) or agents. LoxaSperse™ can be obtainedfrom a bulk source.

As used herein, XyliFos™ refers to an excipient base powder comprisingxylitol, poloxamer 407, hydroxylpropyl betadex, and epigallocatechingallate. XyliFos™ is used as a chemical dispersing or solubilizingagent, thereby improving the solubility and dispersibility of poorlywater soluble active pharmaceutical ingredients (APIs) or agents. In anaspect, infectious agents such as bacteria and fungi can consume oruptake XyliFos™, but cannot digest, process, or excrete XyliFos™. Thisleads to the infectious agent's death. XyliFos™ can be obtained from abulk source.

As described herein, the combined use of LoxaSperse and XyliFos canimprove the efficiency and performance of the disclosed compoundedcomposition as XyliFos improves the solubilizing and dispensingcharacteristics of LoxaSperse.

Disclosed are the components to be used to prepare a composition of theinvention as well as the compositions themselves to be used within themethods disclosed herein. These and other materials are disclosedherein, and it is understood that when combinations, subsets,interactions, groups, etc. of these materials are disclosed that whilespecific reference of each various individual and collectivecombinations and permutation of these compounds cannot be explicitlydisclosed, each is specifically contemplated and described herein. Forexample, if a particular compound is disclosed and discussed and anumber of modifications that can be made to a number of moleculesincluding the compounds are discussed, specifically contemplated is eachand every combination and permutation of the compound and themodifications that are possible unless specifically indicated to thecontrary. Thus, if a class of molecules A, B, and C are disclosed aswell as a class of molecules D, E, and F and an example of a combinationmolecule, A-D is disclosed, then even if each is not individuallyrecited each is individually and collectively contemplated meaningcombinations, A-E, A-F, B-D, B-E, B-F, C-D, C-E, and C-F are considereddisclosed. Likewise, any subset or combination of these is alsodisclosed. Thus, for example, the sub-group of A-E, B-F, and C-E wouldbe considered disclosed. This concept applies to all aspects of thisapplication including, but not limited to, steps in methods of makingand using the compositions of the invention. Thus, if there are avariety of additional steps that can be performed it is understood thateach of these additional steps can be performed with any specificembodiment or combination of embodiments of the methods of theinvention.

B. Compounded Compositions

Disclosed herein is a compounded composition for treating an infection.

1. Compounded Composition Comprising an Anti-Bacterial Agent and/or anAnti-Fungal Agent

Disclosed herein is a compounded composition comprising atherapeutically effective amount of a first anti-bacterial agent and atherapeutically effective amount of a second anti-bacterial agent. Adisclosed compounded composition can comprise a dry powder formulationor can comprise an ointment.

In an aspect, a disclosed compounded composition can comprise from about1.0% w/w to about 9.0% w/w, from about 2.0% w/w to about 8.0% w/w, fromabout 3.0% w/w to about 7.0% w/w, or from about 4.0% w/w to about 7.0%w/w of the first anti-bacterial agent. In an aspect, a disclosedcompounded composition can comprise from about 1.0% w/w to about 9.0%w/w, from about 2.0% w/w to about 8.0% w/w, from about 3.0% w/w to about7.0% w/w, or from about 4.0% w/w to about 7.0% w/w of the secondanti-bacterial agent.

Anti-bacterial agents are known to the art and discussed supra.

In an aspect, the first anti-bacterial agent can comprise mupirocin.Mupirocin is known to the art and discussed supra.

In an aspect, the second anti-bacterial agent can comprise tobramycin ora pharmaceutically acceptable salt thereof. In an aspect, a disclosedcompounded composition can comprise mupirocin and tobramycin. In anaspect, the mupirocin can comprise an ointment (for example, a mupirocin2.0% ointment) and the tobramycin or a pharmaceutically acceptable saltthereof can comprise a dry powder. In an aspect, a disclosed compoundedcomposition can comprise about 1.775% w/w mupirocin and about 7.5% w/wtobramycin or a pharmaceutically acceptable salt thereof.

In an aspect, the second anti-bacterial agent can comprise tobramycinsulfate. In an aspect, a disclosed compounded composition can comprisemupirocin and tobramycin sulfate. In an aspect, the mupirocin cancomprise an ointment (for example, a mupirocin 2.0% ointment) and thetobramycin sulfate can comprise a dry powder.

In an aspect, the second anti-bacterial agent can comprise doxycyclineor a pharmaceutically acceptable salt thereof. In an aspect, a disclosedcompounded composition can comprise mupirocin and doxycycline or apharmaceutically acceptable salt thereof. In an aspect, the mupirocincan comprise an ointment (for example, a mupirocin 2.0% ointment) andthe doxycycline or a pharmaceutically acceptable salt thereof cancomprise a dry powder. In an aspect, a disclosed compounded compositioncan comprise about 1.756% w/w mupirocin and about 5.0% w/w doxycyclineor a pharmaceutically acceptable salt thereof.

In an aspect, the second anti-bacterial agent can comprise doxycyclinehyclate. In an aspect, a disclosed compounded composition can comprisemupirocin and doxycycline hyclate. In an aspect, the mupirocin cancomprise an ointment (for example, a mupirocin 2.0% ointment) and thedoxycycline hyclate can comprise a dry powder.

In an aspect, the second anti-bacterial agent can comprise azithromycin.In an aspect, a disclosed compounded composition can comprise mupirocinand azithromycin. In an aspect, the mupirocin can comprise an ointment(for example, a mupirocin 2.0% ointment) and the azithromycin cancomprise a dry powder. In an aspect, a disclosed compounded compositioncan comprise about 1.8% w/w mupirocin and about 5.0% w/w azithromycin.

In an aspect, a disclosed compounded composition can comprise atherapeutically effective amount of one or more additionalanti-infective agents. In an aspect, the additional anti-infective agentcan be an anti-bacterial agent. Anti-bacterial agents are known to theart and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra.

In an aspect, the anti-fungal agent can comprise ketoconazole. In anaspect, a disclosed compounded composition can comprise mupirocin,doxycycline or a pharmaceutically acceptable salt thereof), andketoconazole. In an aspect, the mupirocin can comprise an ointment (forexample, a mupirocin 2.0% ointment), the doxycycline or apharmaceutically acceptable salt thereof can comprise a dry powder, andthe ketoconazole can comprise a dry powder. In an aspect, a disclosedcompounded composition can comprise about 1.6% w/w mupirocin, about 5.0%w/w doxycycline or a pharmaceutically acceptable salt thereof, and about5.0% w/w ketoconazole.

In an aspect, a disclosed compounded composition can comprise one ormore excipients or additives. In an aspect, excipients or additivesinclude, but are not limited to, the following: solvents, surfactants,humectants, preservatives, flavorings, stabilizers (includingantioxidants), binders, and colorants.

Disclosed herein is a compounded composition comprising atherapeutically effective amount of a first anti-bacterial agent, atherapeutically effective amount of a second antibacterial agent, and atherapeutically effective amount of an anti-fungal agent. In an aspect,a disclosed compounded composition can comprise mupirocin, doxycyclineor a pharmaceutically acceptable salt thereof, and ketoconazole. In anaspect, the mupirocin can comprise an ointment, the doxycycline cancomprise a dry powder, and the ketoconazole can comprise a dry powder.In an aspect, a disclosed compounded composition can comprise about 1.6%w/w mupirocin, about 5.0% w/w doxycycline or a pharmaceuticallyacceptable salt thereof, and about 5.0% w/w ketoconazole.

In an aspect, a compounded composition comprises an antibacterial agentand an antifungal agent. The antibacterial agent may comprisedoxycycline, tobramycin, ciprofloxacin, mupirocin, or combinationthereof. The antifungal agent my comprise ketoconazole. In oneembodiment, the compounded composition comprises doxycycline,ciprofloxacin, mupirocin, and ketoconazole. In another embodiment, thecompounded composition comprises doxycycline, tobramycin, mupirocin, andketoconazole. In some such embodiments, the compounded compositioncomprises a compounded ointment.

In an aspect, the antibacterial agent may comprise any amount by weightdescribed herein. For example, in various embodiments, the doxycyclinemay be present in an amount between approximately 0.1% and approximately10%, approximately 1% and approximately 7%, approximately 2% andapproximately 5% by weight of the compounded composition; one ofciprofloxacin or tobramycin may be present in an amount betweenapproximately 0.1% and approximately 10%, approximately 1% andapproximately 7%, approximately 2% and approximately 5% by weight of thecompounded composition; and the mupirocin may be present in an amountbetween approximately 0.1% and approximately 10%, approximately 1% andapproximately 7%, approximately 1.5% and approximately 4% by weight ofthe compounded composition. The antifungal agent may comprise any amountby weight described herein. For example, the ketoconazole may be presentin an amount between approximately 0.1% and approximately 10%,approximately 1% and approximately 7%, approximately 2% andapproximately 5% by weight of the compounded composition.

In an aspect, the compounded composition comprises an antibacterialagent comprising approximately 2.5% doxycycline by weight, approximately2.5% ciprofloxacin by weight, and approximately 1.7% mupirocin byweight; and an antifungal agent comprising approximately 2.5%ketoconazole by weight. In another embodiment, the compoundedcomposition comprises an antibacterial agent comprising approximately2.5% doxycycline by weight, approximately 2.5% tobramycin by weight, andapproximately 1.7% mupirocin by weight; and an antifungal agentcomprising approximately 2.5% ketoconazole by weight.

In an aspect, a treatment solution for a footbath a commerciallyavailable clindamycin solution and a diluent, such as any diluentdescribed herein. In one example, the clindamycin solution comprises a1% clindamycin solution. In another example, the treatment solutioncomprises approximately 30 mL or 60 mL 1% clindamycin solution with asuitable amount of diluent for the footbath.

In an aspect, a treatment solution for a footbath a commerciallyavailable erythromycin solution and a diluent, such as any diluentdescribed herein. In one example, the erythromycin solution comprises a2% erythromycin solution. In another example, the treatment solutioncomprises approximately 30 mL or 60 mL 2% erythromycin solution with asuitable amount of diluent for the footbath.

In an aspect, a compounded composition comprising a treatment solutionincludes a therapeutically effective amount of the anti-bacterial agentlevofloxacin and a diluent, such as any suitable diluent for topicaladministration. In various embodiments, the treatment solution iscompounded from commercially available levofloxacin bulk powder, groundlevofloxacin tablets, levofloxacin oral solution, levofloxacin forinjection, or a combination thereof. In an aspect, a suitable diluentcomprises one or more aqueous diluents. In one aspect, all or a portionof the diluent may be selected from water, sodium hydroxide, saline,Dakin's solution, sodium hypochlorite, or combination thereof. In oneexample, the diluent comprises sterile water for irrigation. In variousembodiments, the treatment solution comprises levofloxacin oralsolution. For example, the treatment solution may comprise commerciallyavailable oral solution of levofloxacin and diluent, such aslevofloxacin 125 mg/5 mL (25 mg/mL) solution. In a further aspect, amethod of treating a bacterial infection may include topicallyadministering the levofloxacin oral solution to an affected outside bodyregion such as an outer or external body surface such as skin. Thetopical administration may include a bathing administration, which mayinclude submerging all or a portion of an affected body region orsurface in the treatment solution, e.g., in a bath application,irrigating all or a portion of the affected body region or surface withthe treatment solution in an irrigation application, or otherwisecontacting all or a portion of the affected body region or surface withthe treatment solution, such as by spraying the treatment solution ontoall or a portion of the affected body region or surface in a topicalspray application.

In an aspect, a treatment solution may contain between about 1 mg andabout 2000 mg, such as between about 100 mg and about 1000 mg, about 250mg and bout 750 mg, about 250 mg, about 500 mg, or about 750 mglevofloxacin in a dosage volume. According to various embodiments, adosage volume may be about 20 mL to about 4 L, such as about 30 mL toabout 2 L, about 40 mL to about 1.5 L, or about 40 mL to about 1 L.

In an aspect, a treatment solution may include about 0.01 mg/mL to about24 mg/mL levofloxacin, such as about 0.5 mg/mL to about 2 mg/mL, about 1mg/mL to about 10 mg/mL, about 5 mg/mL to about 13 mg/mL, about 10 mg/mLto about 20 mg/mL. In an aspect, the treatment solution may includegreater than a 25 mg/mL levofloxacin concentration.

In an aspect, a compounded composition comprising a treatment solutionincludes a therapeutically effective amount of the anti-bacterial agentlinezolid and a diluent, such as any suitable diluent for topicaladministration. In various embodiments, the treatment solution iscompounded from commercially available linezolid bulk powder, groundlinezolid tablets, linezolid solution, linezolid solution of injectionor infusion, or a combination thereof. In an aspect, a suitable diluentcomprises one or more aqueous diluents. In one aspect, all or a portionof the diluent may be selected from water, sodium hydroxide, saline,Dakin's solution, sodium hypochlorite, or combination thereof. In oneexample, the diluent comprises sterile water for irrigation. In variousembodiments, the treatment solution comprises all or a portion of alinezolid tablet dissolved, dispersed, or suspended in diluent. Forexample, the treatment solution may comprise commercially availablelinezolid tablets and diluent, such as linezolid 600 mg tablets, wherebythe linezolid tablets may have be ground into a fine powder and combinedwith the diluent. In a further aspect, a method of treating a bacterialinfection may include topically administering the treatment solution toan affected outside body region such as an outer or external bodysurface such as skin. The topical administration may include a bathingadministration, which may include submerging all or a portion of anaffected body region or surface in the treatment solution, e.g., in abath application, irrigating all or a portion of the affected bodyregion or surface with the treatment solution in an irrigationapplication, or otherwise contacting all or a portion of the affectedbody region or surface with the treatment solution, such as by sprayingthe treatment solution onto all or a portion of the affected body regionor surface in a spray application.

In an aspect, a treatment solution may contain between about 1 mg andabout 2000 mg, such as between about 100 mg and about 1000 mg, about 150mg and about 750 mg, about 200 mg and about 500 mg, such as about 200mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 500mg, about 550 mg, or about 600 mg linezolid in a dosage volume.According to various embodiments, a dosage volume may be about 20 mL toabout 4 L, such as about 30 mL to about 2 L, about 40 mL to about 1.5 L,or about 40 mL to about 1 L.

In an aspect, a treatment solution may include about 0.01 mg/mL to about2 mg/mL linezolid, such as about 0.075 mg/mL to about 1 mg/mL, about 0.1to about 0.5 mg/mL, about 0.1 to about 0.4 mg/mL, about 0.15 mg/mL toabout 0.2 mg/mL, about 0.075 mg/mL to about 0.15 mg/mL. In an aspect,the treatment solution may include greater than a 0.15 mg/mL linezolidconcentration.

Disclosed herein can be a compounded composition comprising ananti-bacterial agent, an anti-fungal agent, and an excipient base powdercomprising a blend of micronized xylitol and poloxamers.

In an aspect, the compounded composition can be a dry powderformulation. In an aspect, the anti-bacterial agent can be a dry powder.In an aspect, the anti-bacterial agent can be an ointment. Theanti-bacterial agent can be pure or substantially pure. Theanti-bacterial agent can be obtained from a bulk source. In an aspect,the anti-fungal agent can be a dry powder. In an aspect, the anti-fungalagent can be an ointment. The anti-fungal agent can be pure orsubstantially pure. The anti-fungal agent can be obtained from a bulksource.

In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder and XyliFos™ excipient basepowder. In an aspect, an excipient base powder can be obtained from abulk source.

In an aspect, the anti-bacterial agent can comprise from about 10% toabout 40% w/w of the compounded composition. In an aspect, theanti-bacterial agent can comprise from about 15% to about 35% w/w of thecompounded composition. In an aspect, the anti-bacterial agent cancomprise from about 20% to about 30% w/w of the compounded composition.In an aspect, the anti-bacterial agent can comprise about 25% w/w of thecompounded composition.

In an aspect, the anti-fungal agent can comprise from about 10% to about40% w/w of the compounded composition. In an aspect, the anti-fungalagent can comprise from about 15% to about 35% w/w of the compoundedcomposition. In an aspect, the anti-fungal agent can comprise from about20% to about 30% w/w of the compounded composition. In an aspect, theanti-fungal agent can comprise about 25% w/w of the compoundedcomposition.

In an aspect, the ratio of the anti-bacterial agent to the anti-fungalagent in the compounded composition can be from about 1:4 to about 4:1.In an aspect, the ratio of the anti-bacterial agent to the anti-fungalagent can be about 1:1. In an aspect, the ratio of the anti-bacterialagent to the anti-fungal agent can be about 1.25:1. For example, Table 1presents a representative, but not exhaustive, listing of the % w/w ofthe components of a disclosed compounded composition. RepresentativeListing of Components (% w/w) in a Compounded Composition

Anti- Anti-Fungal Loxasperse and/or Xylifos 10 10-40 qS 15 10-40 qS 2010-40 qS 25 10-40 qS 30 10-40 qS 35 10-40 qS 40 10-40 qS 10-40 10 qS10-40 15 qS 10-40 20 qS 10-40 25 qS 10-40 30 qS 10-40 35 qS 10-40 40 qS10 10 80 15 15 70 20 20 60 25 25 50 30 30 40 35 35 30 40 40 20

In an aspect, the anti-bacterial agent can comprise afenide, amikacin,amoxicillin, ampicillin, arsphenamine, azithromycin, azlocillin,aztreonam, bacampicillin, bacitracin, carbacephem (loracarbef),carbenicillin, cefaclor, cefadroxil, cefalotin, cefamandole, cefazolin,cefdinir, cefditoren, cefepime, cefixime, cefoperazone, cefotaxime,cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, ceftizoxime,ceftobiprole, ceftriaxone, cefuroxime, cephalexin, chloramphenicol,chlorhexidine, ciprofloxacin, clarithromycin, clavulanic acid,clindamycin, cloxacillin, colimycin, colistimethate teicoplanin,colistin, demeclocycline, dicloxacillin, dirithromycin, doripenem,doxycycline, efprozil, enoxacin, ertapenem, erythromycin, ethambutol,flucloxacillin, fosfomycin, furazolidone, gatifloxacin, geldanamycin,gentamicin, grepafloxacin, herbimycin, imipenem, isoniazid, kanamycin,levofloxacin, lincomycin, linezolid, lomefloxacin, meropenem,meticillin, metronidazole, mezlocillin, minocycline, mitomycin,moxifloxacin, mupirocin, nafcillin, neomycin, netilmicin,nitrofurantoin, norfloxacin, ofloxacin, oxacillin, oxytetracycline,paromomycin, penicillin G, penicillin V, piperacillin, pivmecillinam,platensimycin, polymyxin B, prontosil, pvampicillin, pyrazinamide,quinupristin/dalfopristin, rifampicin, rifampin, roxithromycin,sparfloxacin, spectinomycin, spiramycin, sulbactam, sulfacetamide,sulfamethizole, sulfamethoxazole, sulfanilimide, sulfisoxazole,sulphonamides, sultamicillin, telithromycin, tetracycline,thiamphenicol, ticarcillin, tobramycin, trimethoprim,trimethoprim-sulfamethoxazole, troleandomycin, trovafloxacin, or acombination thereof.

In an aspect, the anti-bacterial agent can comprise mupirocin. In anaspect, the anti-bacterial agent can comprise azithromycin.

In an aspect, the anti-fungal agent can comprise abafungin,albaconazole, amorolfin, amphotericin b, anidulafungin, bifonazole,butenafine, butoconazole, candicidin, caspofungin, ciclopirox,clotrimazole, econazole, fenticonazole, filipin, fluconazole,flucytosine, griseofulvin, haloprogin, hamycin, isavuconazole,isoconazole, itraconazole, ketoconazole, micafungin, miconazole,naftifine, natamycin, nystatin, omoconazole, oxiconazole, polygodial,posaconazole, ravuconazole, rimocidin, sertaconazole, sulconazole,terbinafine, terconazole, tioconazole, tolnaftate, undecylenic acid,voriconazole, or a combination thereof.

In an aspect, the anti-fungal agent can comprise itraconazole. In anaspect, the anti-fungal agent can comprise fluconazole. In an aspect,the anti-fungal agent can comprise nystatin.

In an aspect of a disclosed compounded composition, the anti-bacterialagent can comprise mupirocin and the anti-fungal agent can compriseitraconazole. In an aspect of a disclosed compounded composition, theanti-bacterial agent can comprise azithromycin and the anti-fungal agentcan comprise fluconazole. In an aspect of a disclosed compoundedcomposition, the anti-bacterial agent can comprise mupirocin and theanti-fungal agent can comprise nystatin. In an aspect, a disclosedcompounded composition can comprise one or more additionalanti-infective agents. In an aspect, the additional anti-infective agentcan be a dry powder. In an aspect, the additional anti-infective agentcan be an ointment. The additional anti-infective agent can be pure orsubstantially pure. The additional anti-infective agent can be obtainedfrom a bulk source. In an aspect, the additional anti-infective agentcan be an antibacterial agent. Anti-bacterial agents are known to theart and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra.

In an aspect, a disclosed compounded composition can comprise one ormore excipients or additives. In an aspect, excipients or additivesinclude, but are not limited to, the following: solvents, surfactants,humectants, preservatives, flavorings, stabilizers (includingantioxidants), binders, and colorants.

In an aspect, a disclosed compounded composition comprising ananti-bacterial agent and an anti-fungal agent can be encapsulated in oneor more capsules. The art is familiar with capsules, methods of makingcapsules, and methods of using capsules to encapsulate one or moredisclosed compositions or one or more disclosed agents.

Disclosed herein is a compounded composition comprising atherapeutically effective amount of mupirocin and a therapeuticallyeffective amount of an anti-bacterial agent. In an aspect, a disclosedcompounded composition comprising mupirocin and an anti-bacterial agentcan comprise a dry powder formulation or can comprise an ointment.

In an aspect, a disclosed compounded composition comprising mupirocinand an anti-bacterial agent can comprise from about 1.0% w/w to about3.0% w/w mupirocin. In an aspect, a disclosed compounded compositioncomprising mupirocin and an anti-bacterial agent can comprise about 1.6%w/w, or about 1.756% w/w, or about 1.77% w/w, or about 1.775% w/w, orabout 1.8% w/w mupirocin. In an aspect, a disclosed compoundedcomposition comprising mupirocin and an anti-bacterial agent cancomprise from about 1.0% w/w to about 9.0% w/w, from about 2.0% w/w toabout 8.0% w/w, from about 3.0% w/w to about 7.0% w/w, from about 4.0%w/w to about 6.0% w/w, or about 5.0% w/w of the anti-bacterial agent. Inan aspect, a disclosed compounded composition comprising mupirocin andan anti-bacterial agent can comprise about 2.5% w/w, about 5.0% w/w, orabout 7.5% w/w of the anti-bacterial agent. Anti-bacterial agents areknown to the art and discussed supra.

Disclosed herein is a compounded composition comprising atherapeutically effective amount of mupirocin and a therapeuticallyeffective amount of tobramycin or a pharmaceutically acceptable saltthereof. A disclosed compounded composition comprising mupirocin andtobramycin or a salt thereof can comprise a dry powder formulation orcan comprise an ointment.

In an aspect, a disclosed compounded composition comprising mupirocinand tobramycin or a salt thereof can comprise from about 1.0% w/w toabout 3.0% w/w of mupirocin. In an aspect, a disclosed compoundedcomposition comprising mupirocin and tobramycin or a salt thereof cancomprise about 1.775% w/w of mupirocin. In an aspect, a disclosedcompounded composition comprising mupirocin and tobramycin or a saltthereof can comprise from about 7.0% to about 9.0% w/w of tobramycin ora pharmaceutically acceptable salt thereof. In an aspect, a disclosedcompounded composition comprising mupirocin and tobramycin or a saltthereof can comprise about 7.5% w/w of tobramycin or a pharmaceuticallyacceptable salt thereof. In an aspect, a disclosed compoundedcomposition comprising mupirocin and tobramycin or a salt thereof cancomprise about 1.775% w/w mupirocin and about 7.5% w/w tobramycin or apharmaceutically acceptable salt thereof. In an aspect, a disclosedcompounded composition comprising mupirocin and tobramycin or apharmaceutically acceptable salt thereof can comprise ketoconazole orfluconazole.

Disclosed herein is a compounded composition comprising atherapeutically effective amount of mupirocin and a therapeuticallyeffective amount of doxycycline or a pharmaceutically acceptable saltthereof. A disclosed compounded composition comprising mupirocin anddoxycycline or a salt thereof can comprise a dry powder formulation orcan comprise an ointment. In an aspect, a disclosed compoundedcomposition comprising mupirocin and doxycycline or a salt thereof cancomprise from about 1.0% w/w to about 3.0% w/w mupirocin. In an aspect,a disclosed compounded composition comprising mupirocin and doxycyclineor a salt thereof can comprise about 1.756% w/w mupirocin. In an aspect,a disclosed compounded composition comprising mupirocin and doxycyclineor a salt thereof can comprise from about 4.0% to about 6.0% w/wdoxycycline or a pharmaceutically acceptable salt thereof. In an aspect,a disclosed compounded composition comprising mupirocin and doxycyclineor a salt thereof can comprise about 5.0% w/w doxycycline or apharmaceutically acceptable salt thereof. In an aspect, a disclosedcompounded composition comprising mupirocin and doxycycline or a saltthereof can comprise about 1.756% w/w mupirocin and about 5.0% w/wdoxycycline or a pharmaceutically acceptable salt thereof.

In an aspect, a disclosed compounded composition comprising mupirocinand doxycycline or a salt thereof can comprise ketoconazole. In anaspect, a disclosed compounded composition can comprise about 1.6% w/wmupirocin, about 5.0% w/w doxycycline or a pharmaceutically acceptablesalt thereof, and about 5.0% w/w ketoconazole. In an aspect, a disclosedcompounded composition can comprise about 1.8% w/w mupirocin, about 2.5%w/w doxycycline or a pharmaceutically acceptable salt thereof, and about2.5% w/w ketoconazole.

Disclosed herein is a compounded composition comprising atherapeutically effective amount of mupirocin and a therapeuticallyeffective amount of azithromycin. A disclosed compounded compositioncomprising mupirocin and azithromycin can comprise a dry powderformulation or can comprise an ointment. In an aspect, a disclosedcompounded composition comprising mupirocin and azithromycin cancomprise from about 1.0% w/w to about 3.0% w/w mupirocin. In an aspect,a disclosed compounded composition comprising mupirocin and azithromycincan comprise about 1.8% w/w mupirocin. In an aspect, a disclosedcompounded composition comprising mupirocin and azithromycin cancomprise from about 4.0% w/w to about 6.0% w/w azithromycin. In anaspect, a disclosed compounded composition comprising mupirocin andazithromycin can comprise about 5.0% w/w azithromycin. In an aspect, adisclosed compounded composition can comprise about 1.8% w/w mupirocinand about 5.0% w/w azithromycin.

Disclosed herein is a compounded composition comprising atherapeutically effective amount of mupirocin and a therapeuticallyeffective amount of ciprofloxacin or a pharmaceutically acceptable saltthereof. A disclosed compounded composition comprising mupirocin andciprofloxacin or a salt thereof can comprise a dry powder formulation orcan comprise an ointment. In an aspect, a disclosed compoundedcomposition comprising mupirocin and ciprofloxacin or salt thereof cancomprise from about 1.0% w/w to about 3.0% w/w, from about 1.2% w/w toabout 2.5% w/w, from about 1.4% w/w to about 2.3% w/w, from about 1.4%w/w to about 2.2% w/w, from about 1.5% w/w to about 2.1% w/w, from about1.6% w/w to about 2.0% w/w, from about 1.7% w/w to about 2.0% w/w, orfrom about 1.8% w/w to about 2.0% w/w mupirocin. In an aspect, adisclosed compounded composition comprising mupirocin and ciprofloxacinor salt thereof can comprise from about 1.0% w/w to about 5.0% w/w, fromabout 1.0% w/w to about 3.0% w/w, or from about 1.5% w/w to about 2.5%w/w ciprofloxacin or a pharmaceutically acceptable thereof. In anaspect, a disclosed compounded composition comprising mupirocin andciprofloxacin or salt thereof can comprise from about 1.8% w/w to about2.0% w/w mupirocin and from about 1.0% w/w to about 3.0% w/wciprofloxacin or a pharmaceutically acceptable thereof. In an aspect, adisclosed compounded composition comprising mupirocin and ciprofloxacinor salt thereof can comprise about 1.95% w/w mupirocin and about 2.0%w/w ciprofloxacin or a pharmaceutically acceptable salt thereof.

Disclosed herein is a compounded composition comprising atherapeutically effective amount of mupirocin and a therapeuticallyeffective amount of clindamycin or a pharmaceutically acceptable saltthereof. In an aspect, a disclosed compounded composition comprisingmupirocin and clindamycin or a salt thereof can comprise a dry powderformulation or can comprise an ointment. In an aspect, a disclosedcompounded composition comprising mupirocin and clindamycin or a saltthereof can comprise from about 1.0% w/w to about 3.0% w/w mupirocin. Inan aspect, a disclosed compounded composition comprising mupirocin andclindamycin or a salt thereof can comprise about 1.88% w/w mupirocin. Inan aspect, a disclosed compounded composition can comprise from about4.0% to about 6.0% w/w clindamycin or a pharmaceutically acceptable saltthereof. In an aspect, a disclosed compounded composition comprisingmupirocin and clindamycin or a salt thereof can comprise about 5.0% w/wclindamycin or a pharmaceutically acceptable salt thereof. In an aspect,a disclosed compounded composition comprising mupirocin and clindamycinor a salt thereof can comprise about 1.88% w/w mupirocin and about 5.0%w/w clindamycin or a pharmaceutically acceptable salt thereof.

Mupirocin is known to the art and is discussed supra. Anti-bacterialagents are known to the art and discussed supra. Azithromycin is knownto the art and is discussed supra. Ciprofloxacin as well aspharmaceutically acceptable salts thereof are known to the art and arediscussed supra. Clindamycin as well as pharmaceutically acceptablesalts thereof are known to the art and are discussed supra. Doxycyclineas well as pharmaceutically acceptable salts thereof are known to theart and are discussed supra. Ketoconazole is known to the art and isdiscussed supra. Tobramycin as well as pharmaceutically acceptable saltsthereof are known to the art and are discussed supra.

In an aspect, a disclosed compounded composition can comprise one ormore excipients or additives. In an aspect, excipients or additivesinclude, but are not limited to, the following: solvents, surfactants,humectants, preservatives, flavorings, stabilizers (includingantioxidants), binders, and colorants.

In an aspect, a disclosed compounded composition can comprise atherapeutically effective amount of one or more additionalanti-infective agents. In an aspect, the additional anti-infective agentcan be an anti-bacterial agent. Anti-bacterial agents are known to theart and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra.

2. Compounded Composition Comprising Mupirocin and an Anti-Fungal Agent

Disclosed herein is a compounded composition comprising mupirocin, ananti-fungal agent, and an excipient base powder comprising a blend ofmicronized xylitol and poloxamers.

In an aspect, the compounded composition can be a dry powderformulation.

In an aspect, the mupirocin can be a dry powder. In an aspect, themupirocin can be an ointment. The mupirocin can be pure or substantiallypure. The mupirocin can be obtained from a bulk source. In an aspect,the anti-fungal agent can be a dry powder. In an aspect, the anti-fungalagent can be an ointment. The anti-fungal agent can be pure orsubstantially pure. The anti-fungal agent can be obtained from a bulksource.

In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder and XyliFos™ excipient basepowder. In an aspect, an excipient base powder can be obtained from abulk source.

In an aspect, the anti-fungal agent can comprise abafungin,albaconazole, amorolfin, amphotericin b, anidulafungin, bifonazole,butenafine, butoconazole, candicidin, caspofungin, ciclopirox,clotrimazole, econazole, fenticonazole, filipin, fluconazole,flucytosine, griseofulvin, haloprogin, hamycin, isavuconazole,isoconazole, itraconazole, ketoconazole, micafungin, miconazole,naftifine, natamycin, nystatin, omoconazole, oxiconazole, polygodial,posaconazole, ravuconazole, rimocidin, sertaconazole, sulconazole,terbinafine, terconazole, tioconazole, tolnaftate, undecylenic acid,voriconazole, or a combination thereof. The anti-fungal agent cancomprise itraconazole.

In an aspect, the mupirocin can comprise from about 10% to about 40% w/wof the compounded composition. In an aspect, the mupirocin can comprisefrom about 15% to about 35% w/w of the compounded composition. In anaspect, the mupirocin can comprise from about 20% to about 30% w/w ofthe compounded composition. In an aspect, the mupirocin can compriseabout 25% w/w of the compounded composition.

In an aspect, the anti-fungal agent can comprise from about 10% to about40% w/w of the compounded composition. In an aspect, the anti-fungalagent can comprise from about 15% to about 35% w/w of the compoundedcomposition. In an aspect, the anti-fungal agent can comprise from about20% to about 30% w/w of the compounded composition. In an aspect, theanti-fungal agent can comprise about 25% w/w of the compoundedcomposition.

In an aspect, the ratio of the mupirocin to the anti-fungal agent in thecompounded composition can be from about 1:4 to about 4:1. In an aspect,the ratio of the mupirocin to the anti-fungal agent can be about 1:1. Inan aspect, the ratio of the mupirocin to the anti-fungal agent can beabout 1.25:1. See, e.g., Table 1.

In an aspect, a disclosed compounded composition can comprise one ormore additional anti-infective agents. In an aspect, the additionalanti-infective agent can be a dry powder. In an aspect, the additionalanti-infective agent can be an ointment. The additional anti-infectiveagent can be pure or substantially pure. The additional anti-infectiveagent can be obtained from a bulk source. In an aspect, the additionalanti-infective agent can be an antibacterial agent. Anti-bacterialagents are known to the art and discussed supra. In an aspect, theadditional anti-infective agent can be an anti-fungal agent. Anti-fungalagents are known to the art and discussed supra.

In an aspect, a disclosed compounded composition can comprise one ormore excipients or additives. In an aspect, excipients or additivesinclude, but are not limited to, the following: solvents, surfactants,humectants, preservatives, flavorings, stabilizers (includingantioxidants), binders, and colorants.

In an aspect, a disclosed compounded composition comprising mupirocinand an anti-fungal agent can be encapsulated in one or more capsules.The art is familiar with capsules, methods of making capsules, andmethods of using capsules to encapsulate one or more disclosedcompositions or one or more disclosed agents.

3. Compounded Composition Comprising an Anti-Bacterial Agent andItraconazole

Disclosed herein is a compounded composition comprising ananti-bacterial agent, itraconazole, and an excipient base powdercomprising a blend of micronized xylitol and poloxamers.

In an aspect, the compounded composition can be a dry powderformulation.

In an aspect, the anti-bacterial agent can be a dry powder. In anaspect, the antibacterial agent can be an ointment. The anti-bacterialagent can be pure or substantially pure. The anti-bacterial agent can beobtained from a bulk source. In an aspect, the itraconazole can be a drypowder. In an aspect, the itraconazole can be an ointment. Theitraconazole can be pure or substantially pure. The itraconazole can beobtained from a bulk source.

In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder and XyliFos™ excipient basepowder. In an aspect, an excipient base powder can be obtained from abulk source.

In an aspect, the anti-bacterial agent can comprise from about 10% toabout 40% w/w of the compounded composition. In an aspect, theanti-bacterial agent can comprise from about 15% to about 35% w/w of thecompounded composition. In an aspect, the anti-bacterial agent cancomprise from about 20% to about 30% w/w of the compounded composition.In an aspect, the anti-bacterial agent can comprise about 25% w/w of thecompounded composition.

In an aspect, the itraconazole can comprise from about 10% to about 40%w/w of the compounded composition. In an aspect, the itraconazole cancomprise from about 15% to about 35% w/w of the compounded composition.In an aspect, the itraconazole can comprise from about 20% to about 30%w/w of the compounded composition. In an aspect, the itraconazole cancomprise about 25% w/w of the compounded composition.

In an aspect, the ratio of the anti-bacterial agent to the itraconazolein the compounded composition can be from about 1:4 to about 4:1. In anaspect, the ratio of the antibacterial agent to the itraconazole can beabout 1:1. In an aspect, the ratio of the anti-bacterial agent to theitraconazole can be about 1.25:1. See, e.g., Table 2.

In an aspect, a disclosed compounded composition can comprise one ormore additional anti-infective agents. In an aspect, the additionalanti-infective agent can be a dry powder. In an aspect, the additionalanti-infective agent can be an ointment. The additional anti-infectiveagent can be pure or substantially pure. The additional anti-infectiveagent can be obtained from a bulk source. In an aspect, the additionalanti-infective agent can be an antibacterial agent. Anti-bacterialagents are known to the art and discussed supra. In an aspect, theadditional anti-infective agent can be an anti-fungal agent. Anti-fungalagents are known to the art and discussed supra.

In an aspect, a disclosed compounded composition can comprise one ormore excipients or additives. In an aspect, excipients or additivesinclude, but are not limited to, the following: solvents, surfactants,humectants, preservatives, flavorings, stabilizers (includingantioxidants), binders, and colorants.

In an aspect, a disclosed compounded composition comprising ananti-bacterial agent and itraconazole can be encapsulated in one or morecapsules. The art is familiar with capsules, methods of making capsules,and methods of using capsules to encapsulate one or more disclosedcompositions or one or more disclosed agents.

4. Compounded Composition Comprising Mupirocin and Itraconazole

Disclosed herein is a compounded composition comprising mupirocin,itraconazole, and an excipient base powder comprising a blend ofmicronized xylitol and poloxamers.

In an aspect, the compounded composition can be a dry powderformulation.

In an aspect, the mupirocin can be a dry powder. In an aspect, themupirocin can be an ointment. The mupirocin can be pure or substantiallypure. The mupirocin can be obtained from a bulk source. In an aspect,the itraconazole can be a dry powder. In an aspect, the itraconazole canbe an ointment. The itraconazole can be pure or substantially pure. Theitraconazole can be obtained from a bulk source.

In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder and XyliFos™ excipient basepowder. In an aspect, an excipient base powder can be obtained from abulk source.

In an aspect, the mupirocin can comprise from about 10% to about 40% w/wof the compounded composition. In an aspect, the mupirocin can comprisefrom about 15% to about 35% w/w of the compounded composition. In anaspect, the mupirocin can comprise from about 20% to about 30% w/w ofthe compounded composition. In an aspect, the mupirocin can compriseabout 25% w/w of the compounded composition.

In an aspect, the itraconazole can comprise from about 10% to about 40%w/w of the compounded composition. In an aspect, the itraconazole cancomprise from about 15% to about 35% w/w of the compounded composition.In an aspect, the itraconazole can comprise from about 20% to about 30%w/w of the compounded composition. In an aspect, the itraconazole cancomprise about 25% w/w of the compounded composition.

In an aspect, the ratio of the mupirocin to the itraconazole in thecompounded composition can be from about 1:4 to about 4:1. In an aspect,the ratio of the mupirocin to the itraconazole can be about 1:1. In anaspect, the ratio of the mupirocin to the itraconazole can be about1.25:1. See, for example, Table 2, which presents a representative, butnot exhaustive, listing of the % w/w of mupirocin and itraconazole in adisclosed compounded composition.

In an aspect, a disclosed compounded composition can comprise one ormore additional anti-infective agents. In an aspect, the additionalanti-infective agent can be a dry powder. In an aspect, the additionalanti-infective agent can be an ointment. The additional anti-infectiveagent can be pure or substantially pure. The additional anti-infectiveagent can be obtained from a bulk source. In an aspect, the additionalanti-infective agent can be an antibacterial agent. Anti-bacterialagents are known to the art and discussed supra. In an aspect, theadditional anti-infective agent can be an anti-fungal agent. Anti-fungalagents are known to the art and discussed supra.

In an aspect, a disclosed compounded composition can comprise one ormore excipients or additives. In an aspect, excipients or additivesinclude, but are not limited to, the following: solvents, surfactants,humectants, preservatives, flavorings, stabilizers (includingantioxidants), binders, and colorants.

In an aspect, a disclosed compounded composition comprising mupirocinand itraconazole can be encapsulated in one or more capsules. The art isfamiliar with capsules, methods of making capsules, and methods of usingcapsules to encapsulate one or more disclosed compositions or one ormore disclosed agents.

Disclosed herein is a compounded composition comprising mupirocin,itraconazole, an excipient base powder comprising a blend of micronizedxylitol and poloxamers, and at least one additional anti-infectiveagent.

In an aspect, the compounded composition can be a dry powderformulation.

In an aspect, the mupirocin can be obtained from a bulk source. Themupirocin can be pure or substantially pure. In an aspect, the mupirocincan be an ointment. In an aspect, the itraconazole can be obtained froma bulk source. In an aspect, the itraconazole can be an ointment. Theitraconazole can be pure or substantially pure. In an aspect, theexcipient base powder can comprise Loxasperse™ excipient base powder. Inan aspect, the excipient base powder can comprise Loxasperse™ excipientbase powder and XyliFos™ excipient base powder. In an aspect, anexcipient base powder can be obtained from a bulk source.

In an aspect, the mupirocin can comprise from about 10% to about 40% w/wof the compounded composition. In an aspect, the mupirocin can comprisefrom about 15% to about 35% w/w of the compounded composition. In anaspect, the mupirocin can comprise from about 20% to about 30% w/w ofthe compounded composition. In an aspect, the mupirocin can compriseabout 25% w/w of the compounded composition.

In an aspect, the itraconazole can comprise from about 10% to about 40%w/w of the compounded composition. In an aspect, the itraconazole cancomprise from about 15% to about 35% w/w of the compounded composition.In an aspect, the itraconazole can comprise from about 20% to about 30%w/w of the compounded composition. In an aspect, the itraconazole cancomprise about 25% w/w of the compounded composition.

In an aspect, the ratio of the mupirocin to the itraconazole in thecompounded composition can be from about 1:4 to about 4:1. In an aspect,the ratio of the mupirocin to the itraconazole can be about 1:1. In anaspect, the ratio of the mupirocin to the itraconazole can be about1.25:1. See, e.g., Table 2.

In an aspect, the additional anti-infective agent can be a dry powder.In an aspect, the additional anti-infective agent can be an ointment.The additional anti-infective agent can be pure or substantially pure.The additional anti-infective agent can be obtained from a bulk source.In an aspect, the additional anti-infective agent can be ananti-bacterial agent. Anti-bacterial agents are known to the art anddiscussed supra. In an aspect, the additional anti-infective agent canbe an anti-fungal agent. Anti-fungal agents are known to the art anddiscussed supra.

In an aspect, a disclosed compounded composition can comprise one ormore excipients or additives. In an aspect, excipients or additivesinclude, but are not limited to, the following: solvents, surfactants,humectants, preservatives, flavorings, stabilizers (includingantioxidants), binders, and colorants.

In an aspect, a disclosed compounded composition comprising mupirocin,itraconazole, and at least one additional anti-infective agent can beencapsulated in one or more capsules. The art is familiar with capsules,methods of making capsules, and methods of using capsules to encapsulateone or more disclosed compositions or one or more disclosed agents.

5. Compounded Composition Comprising Azithromycin and an Anti-FungalAgent

Disclosed herein is a compounded composition comprising azithromycin, ananti-fungal agent, and an excipient base powder comprising a blend ofmicronized xylitol and poloxamers.

In an aspect, the compounded composition can be a dry powderformulation.

In an aspect, the azithromycin can be a dry powder. In an aspect, theazithromycin can be an ointment. The azithromycin can be pure orsubstantially pure. The azithromycin can be obtained from a bulk source.In an aspect, the anti-fungal agent can be a dry powder. In an aspect,the anti-fungal agent can be an ointment. The anti-fungal agent can bepure or substantially pure. The anti-fungal agent can be obtained from abulk source.

In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder and XyliFos™ excipient basepowder. In an aspect, an excipient base powder can be obtained from abulk source.

In an aspect, the azithromycin can comprise from about 10% to about 60%w/w of the compounded composition. In an aspect, the azithromycin cancomprise from about 20% to about 50% w/w of the compounded composition.In an aspect, the azithromycin can comprise from about 30% to about 40%w/w of the compounded composition. In an aspect, the azithromycin cancomprise about 25% w/w of the compounded composition. In an aspect, theazithromycin can comprise about 50% w/w of the compounded composition.

In an aspect, the anti-fungal agent can comprise from about 10% to about60% w/w of the compounded composition. In an aspect, the anti-fungalagent can comprise from about 20% to about 50% w/w of the compoundedcomposition. In an aspect, the anti-fungal agent can comprise from about30% to about 40% w/w of the compounded composition. In an aspect, theanti-fungal agent can comprise about 25% w/w of the compoundedcomposition. In an aspect, the anti-fungal agent can comprise about 50%w/w of the compounded composition.

In an aspect, the ratio of the azithromycin to the anti-fungal agent inthe compounded composition can be from about 1:4 to about 4:1. In anaspect, the ratio of the azithromycin to the anti-fungal agent can beabout 1:1. In an aspect, the ratio of the azithromycin to theanti-fungal agent can be about 1.25:1.

In an aspect, anti-fungal agent can comprise abafungin, albaconazole,amorolfin, amphotericin b, anidulafungin, bifonazole, butenafine,butoconazole, candicidin, caspofungin, ciclopirox, clotrimazole,econazole, fenticonazole, filipin, fluconazole, flucytosine,griseofulvin, haloprogin, hamycin, isavuconazole, isoconazole,itraconazole, ketoconazole, micafungin, miconazole, naftifine,natamycin, nystatin, omoconazole, oxiconazole, polygodial, posaconazole,ravuconazole, rimocidin, sertaconazole, sulconazole, terbinafine,terconazole, tioconazole, tolnaftate, undecylenic acid, voriconazole, ora combination thereof.

In an aspect, the anti-fungal agent can comprise fluconazole.

In an aspect, a disclosed compounded composition comprising azithromycinand an anti-fungal agent can comprise one or more additionalanti-infective agents. In an aspect, the additional anti-infective agentcan be a dry powder. In an aspect, the additional anti-infective agentcan be an ointment. The additional anti-infective agent can be pure orsubstantially pure. The additional anti-infective agent can be obtainedfrom a bulk source. In an aspect, the additional anti-infective agentcan be an anti-bacterial agent. Anti-bacterial agents are known to theart and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra.

In an aspect, a disclosed compounded composition can comprise one ormore excipients or additives. In an aspect, excipients or additivesinclude, but are not limited to, the following: solvents, surfactants,humectants, preservatives, flavorings, stabilizers (includingantioxidants), binders, and colorants.

In an aspect, a disclosed compounded composition comprising azithromycinand an anti-fungal agent can be encapsulated in one or more capsules.The art is familiar with capsules, methods of making capsules, andmethods of using capsules to encapsulate one or more disclosedcompositions or one or more disclosed agents.

6. Compounded Composition Comprising an Anti-Bacterial Agent andFluconazole

Disclosed herein is a compounded composition comprising ananti-bacterial agent, fluconazole, and an excipient base powdercomprising a blend of micronized xylitol and poloxamers.

In an aspect, the compounded composition can be a dry powderformulation.

In an aspect, the anti-bacterial agent can be a dry powder. In anaspect, the antibacterial agent can be an ointment. The anti-bacterialagent can be pure or substantially pure. The anti-bacterial agent can beobtained from a bulk source. In an aspect, the fluconazole can be a drypowder. In an aspect, the fluconazole can be an ointment. Thefluconazole can be pure or substantially pure. The fluconazole can beobtained from a bulk source.

In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder and XyliFos™ excipient basepowder. In an aspect, an excipient base powder can be obtained from abulk source.

In an aspect, the anti-bacterial agent can comprise from about 10% toabout 60% w/w of the compounded composition. In an aspect, theanti-bacterial agent can comprise from about 20% to about 50% w/w of thecompounded composition. In an aspect, the anti-bacterial agent cancomprise from about 30% to about 40% w/w of the compounded composition.In an aspect, the anti-bacterial agent can comprise about 25% w/w of thecompounded composition. In an aspect, the anti-bacterial agent cancomprise about 50% w/w of the compounded composition.

In an aspect, the fluconazole agent can comprise from about 10% to about60% w/w of the compounded composition. In an aspect, the fluconazole cancomprise from about 20% to about 50% w/w of the compounded composition.In an aspect, the fluconazole can comprise from about 30% to about 40%w/w of the compounded composition. In an aspect, the fluconazole cancomprise about 25% w/w of the compounded composition. In an aspect, thefluconazole can comprise about 50% w/w of the compounded composition.

In an aspect, the ratio of the anti-bacterial agent to the fluconazolein the compounded composition can be from about 1:4 to about 4:1. In anaspect, the ratio of the antibacterial agent to the fluconazole can beabout 1:1. In an aspect, the ratio of the anti-bacterial agent to thefluconazole can be about 1.25:1.

In an aspect, the anti-bacterial agent can comprise afenide, amikacin,amoxicillin, ampicillin, arsphenamine, azithromycin, azlocillin,aztreonam, bacampicillin, bacitracin, carbacephem (loracarbef),carbenicillin, cefaclor, cefadroxil, cefalotin, cefamandole, cefazolin,cefdinir, cefditoren, cefepime, cefixime, cefoperazone, cefotaxime,cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, ceftizoxime,ceftobiprole, ceftriaxone, cefuroxime, cephalexin, chloramphenicol,chlorhexidine, ciprofloxacin, clarithromycin, clavulanic acid,clindamycin, cloxacillin, colimycin, colistimethate teicoplanin,colistin, demeclocycline, dicloxacillin, dirithromycin, doripenem,doxycycline, efprozil, enoxacin, ertapenem, erythromycin, ethambutol,flucloxacillin, fosfomycin, furazolidone, gatifloxacin, geldanamycin,gentamicin, grepafloxacin, herbimycin, imipenem, isoniazid, kanamycin,levofloxacin, lincomycin, linezolid, lomefloxacin, meropenem,meticillin, metronidazole, mezlocillin, minocycline, mitomycin,moxifloxacin, mupirocin, nafcillin, neomycin, netilmicin,nitrofurantoin, norfloxacin, ofloxacin, oxacillin, oxytetracycline,paromomycin, penicillin G, penicillin V, piperacillin, pivmecillinam,platensimycin, polymyxin B, prontosil, pvampicillin, pyrazinamide,quinupristin/dalfopristin, rifampicin, rifampin, roxithromycin,sparfloxacin, spectinomycin, spiramycin, sulbactam, sulfacetamide,sulfamethizole, sulfamethoxazole, sulfanilimide, sulfisoxazole,sulphonamides, sultamicillin, telithromycin, tetracycline,thiamphenicol, ticarcillin, tobramycin, trimethoprim,trimethoprim-sulfamethoxazole, troleandomycin, trovafloxacin, or acombination thereof.

In an aspect, the anti-bacterial agent can comprise azithromycin.

In an aspect, a disclosed compounded composition comprising ananti-bacterial agent and fluconazole can comprise one or more additionalanti-infective agents. In an aspect, the additional anti-infective agentcan be a dry powder. In an aspect, the additional anti-infective agentcan be an ointment. The additional anti-infective agent can be pure orsubstantially pure. The additional anti-infective agent can be obtainedfrom a bulk source. In an aspect, the additional anti-infective agentcan be an anti-bacterial agent. Anti-bacterial agents are known to theart and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra.

In an aspect, a disclosed compounded composition can comprise one ormore excipients or additives. In an aspect, excipients or additivesinclude, but are not limited to, the following: solvents, surfactants,humectants, preservatives, flavorings, stabilizers (includingantioxidants), binders, and colorants.

In an aspect, a disclosed compounded composition comprising ananti-bacterial agent and fluconazole can be encapsulated in one or morecapsules. The art is familiar with capsules, methods of making capsules,and methods of using capsules to encapsulate one or more disclosedcompositions or one or more disclosed agents.

7. Compounded Composition Comprising Azithromycin and Fluconazole

Disclosed herein is a compounded composition comprising azithromycin,fluconazole, and an excipient base powder comprising a blend ofmicronized xylitol and poloxamers.

In an aspect, the compounded composition can be a dry powderformulation.

In an aspect, the azithromycin can be a dry powder. In an aspect, theazithromycin can be an ointment. The azithromycin can be pure orsubstantially pure. The azithromycin can be obtained from a bulk source.In an aspect, the fluconazole can be a dry powder. In an aspect, thefluconazole can be an ointment. The fluconazole can be pure orsubstantially pure. The fluconazole can be obtained from a bulk source.

In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder and XyliFos™ excipient basepowder. In an aspect, an excipient base powder can be obtained from abulk source.

In an aspect, the azithromycin can comprise from about 10% to about 60%w/w of the compounded composition. In an aspect, the azithromycin cancomprise from about 20% to about 50% w/w of the compounded composition.In an aspect, the azithromycin can comprise from about 30% to about 40%w/w of the compounded composition. In an aspect, the azithromycin cancomprise about 25% w/w of the compounded composition. In an aspect, theazithromycin can comprise about 50% w/w of the compounded composition.

In an aspect, the fluconazole can comprise from about 10% to about 60%w/w of the compounded composition. In an aspect, the fluconazole cancomprise from about 20% to about 50% w/w of the compounded composition.In an aspect, the fluconazole can comprise from about 30% to about 40%w/w of the compounded composition. In an aspect, the fluconazole cancomprise about 25% w/w of the compounded composition. In an aspect, thefluconazole can comprise about 50% w/w of the compounded composition.

In an aspect, the ratio of the azithromycin to the fluconazole in thecompounded composition can be from about 1:4 to about 4:1. In an aspect,the ratio of the azithromycin to the fluconazole can be about 1:1. In anaspect, the ratio of the azithromycin to the fluconazole can be about1.25:1. See, e.g., Table 3 which presents a representative, but notexhaustive, listing of the % w/w of azithromycin to fluconazole in adisclosed compounded composition.

In an aspect, the compounded composition comprising azithromycin andfluconazole can comprise at least one additional anti-infective agent.In an aspect, the additional anti-infective agent can be a dry powder.In an aspect, the additional anti-infective agent can be an ointment.The additional anti-infective agent can be pure or substantially pure.The additional anti-infective agent can be obtained from a bulk source.In an aspect, the additional anti-infective agent can be ananti-bacterial agent. Anti-bacterial agents are known to the art anddiscussed supra. In an aspect, the additional anti-infective agent canbe an anti-fungal agent. Anti-fungal agents are known to the art anddiscussed supra.

In an aspect, a disclosed compounded composition can comprise one ormore excipients or additives. In an aspect, excipients or additivesinclude, but are not limited to, the following: solvents, surfactants,humectants, preservatives, flavorings, stabilizers (includingantioxidants), binders, and colorants.

In an aspect, a disclosed compounded composition comprising azithromycinand fluconazole can be encapsulated in one or more capsules. The art isfamiliar with capsules, methods of making capsules, and methods of usingcapsules to encapsulate one or more disclosed compositions or one ormore disclosed agents.

Disclosed herein is a compounded composition comprising azithromycin,fluconazole, an excipient base powder comprising a blend of micronizedxylitol and poloxamers, and at least one additional anti-infectiveagent.

In an aspect, the compounded composition can be a dry powderformulation.

In an aspect, the azithromycin can be a dry powder. In an aspect, theazithromycin can be an ointment. The azithromycin can be pure orsubstantially pure. The azithromycin can be obtained from a bulk source.In an aspect, the fluconazole can be a dry powder. In an aspect, thefluconazole can be an ointment. The fluconazole can be pure orsubstantially pure. The fluconazole can be obtained from a bulk source.

In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder and XyliFos™ excipient basepowder. In an aspect, an excipient base powder can be obtained from abulk source.

In an aspect, the azithromycin can comprise from about 10% to about 60%w/w of the compounded composition. In an aspect, the azithromycin cancomprise from about 20% to about 50% w/w of the compounded composition.In an aspect, the azithromycin can comprise from about 30% to about 40%w/w of the compounded composition. In an aspect, the azithromycin cancomprise about 25% w/w of the compounded composition. In an aspect, theazithromycin can comprise about 50% w/w of the compounded composition.

In an aspect, the fluconazole can comprise from about 10% to about 60%w/w of the compounded composition. In an aspect, the fluconazole cancomprise from about 20% to about 50% w/w of the compounded composition.In an aspect, the fluconazole can comprise from about 30% to about 40%w/w of the compounded composition. In an aspect, the fluconazole cancomprise about 25% w/w of the compounded composition. In an aspect, thefluconazole can comprise about 50% w/w of the compounded composition.

In an aspect, the ratio of the azithromycin to fluconazole in thecompounded composition can be from about 1:4 to about 4:1. In an aspect,the ratio of the azithromycin to the fluconazole can be about 1:1. In anaspect, the ratio of the azithromycin to the fluconazole can be about1.25:1. See, e.g., Table 3.

In an aspect, the additional anti-infective agent can be a dry powder.In an aspect, the additional anti-infective agent can be an ointment.The additional anti-infective agent can be pure or substantially pure.The additional anti-infective agent can be obtained from a bulk source.In an aspect, the additional anti-infective agent can be ananti-bacterial agent. Anti-bacterial agents are known to the art anddiscussed supra. In an aspect, the additional anti-infective agent canbe an anti-fungal agent. Anti-fungal agents are known to the art anddiscussed supra.

In an aspect, a disclosed compounded composition can comprise one ormore excipients or additives. In an aspect, excipients or additivesinclude, but are not limited to, the following: solvents, surfactants,humectants, preservatives, flavorings, stabilizers (includingantioxidants), binders, and colorants.

In an aspect, a disclosed compounded composition comprisingazithromycin, fluconazole, and at least one additional anti-infectiveagent can be encapsulated in one or more capsules. The art is familiarwith capsules, methods of making capsules, and methods of using capsulesto encapsulate one or more disclosed compositions or one or moredisclosed agents.

8. Compounded Composition Comprising Mupirocin and Nystatin

Disclosed herein can be a compounded composition comprising mupirocin,nystatin, and an excipient base powder comprising a blend of micronizedxylitol and poloxamers.

In an aspect, the compounded composition can be a dry powderformulation.

In an aspect, the mupirocin can be obtained from a bulk source. Themupirocin can be pure or substantially pure. In an aspect, the mupirocincan be a dry powder. In an aspect, the mupirocin can be an ointment. Inan aspect, the mupirocin can be a 2% ointment. In an aspect, themupirocin can be provided in a tube. For example, in an aspect, themupirocin can be provided in a 22 gram tube. In an aspect, the nystatincan be obtained from a bulk source. The nystatin can be pure orsubstantially pure. In an aspect, the nystatin can be a dry powder. Inan aspect, the nystatin can be an ointment. In an aspect, the nystatincan be provided in a container. For example, in an aspect, the nystatincan be provided in 15 gram container.

In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder and XyliFos™ excipient basepowder. In an aspect, an excipient base powder can be obtained from abulk source.

In an aspect, the mupirocin can comprise from about 10% to about 40% w/wof the compounded composition. In an aspect, the mupirocin can comprisefrom about 15% to about 35% w/w of the compounded composition. In anaspect, the mupirocin can comprise from about 20% to about 30% w/w ofthe compounded composition. In an aspect, the mupirocin can compriseabout 25% w/w of the compounded composition.

In an aspect, the nystatin can comprise from about 10% to about 40% w/wof the compounded composition. In an aspect, the nystatin can comprisefrom about 15% to about 35% w/w of the compounded composition. In anaspect, the nystatin can comprise from about 20% to about 30% w/w of thecompounded composition. In an aspect, the nystatin can comprise about25% w/w of the compounded composition. In an aspect, the ratio of themupirocin to the nystatin in the compounded composition can be fromabout 1:4 to about 4:1. In an aspect, the ratio of the mupirocin to thenystatin can be about 1:1 or the ratio can be about 1.5:1.

In an aspect, a disclosed compounded composition can comprise one ormore additional anti-infective agents. In an aspect, the additionalanti-infective agent can be a dry powder. In an aspect, the additionalanti-infective agent can be an ointment. The additional anti-infectiveagent can be pure or substantially pure. The additional anti-infectiveagent can be obtained from a bulk source. In an aspect, the additionalanti-infective agent can be an antibacterial agent. Anti-bacterialagents are known to the art and discussed supra. In an aspect, theadditional anti-infective agent can be an anti-fungal agent. Anti-fungalagents are known to the art and discussed supra.

In an aspect, a disclosed compounded composition can comprise one ormore excipients or additives. In an aspect, excipients or additivesinclude, but are not limited to, the following: solvents, surfactants,humectants, preservatives, flavorings, stabilizers (includingantioxidants), binders, and colorants.

In an aspect, a disclosed compounded composition comprising mupirocinand nystatin can be encapsulated in one or more capsules. The art isfamiliar with capsules, methods of making capsules, and methods of usingcapsules to encapsulate one or more disclosed compositions or one ormore disclosed agents.

C. Capsules

1. Capsules Comprising a Compounded Composition

Disclosed herein is a capsule comprising a disclosed compoundedcomposition.

Disclosed herein is a capsule comprising a compounded composition,wherein the compounded composition comprises an anti-bacterial agent andan anti-fungal agent.

Disclosed herein is a capsule comprising a compounded composition,wherein the compounded composition comprises an anti-bacterial agent, ananti-fungal agent, and Loxasperse™ excipient base powder.

Disclosed herein is a capsule comprising a compounded composition,wherein the compounded composition comprises an anti-bacterial agent, ananti-fungal agent, and an excipient base powder comprising a blend ofmicronized xylitol and poloxamers.

In an aspect, the encapsulated compounded composition can be a drypowder formulation. In an aspect, the anti-bacterial agent can be a drypowder. In an aspect, the anti-bacterial agent can be an ointment. Theanti-bacterial agent can be pure or substantially pure. Theanti-bacterial agent can be obtained from a bulk source. In an aspect,the anti-fungal agent can be a dry powder. In an aspect, the anti-fungalagent can be an ointment. The anti-fungal agent can be pure orsubstantially pure. The anti-fungal agent can be obtained from a bulksource. In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder and XyliFos™ excipient basepowder. In an aspect, an excipient base powder can be obtained from abulk source.

In an aspect, the anti-bacterial agent can comprise from about 10% toabout 40% w/w of the encapsulated compounded composition. In an aspect,the anti-bacterial agent can comprise from about 15% to about 35% w/w ofthe encapsulated compounded composition. In an aspect, theanti-bacterial agent can comprise from about 20% to about 30% w/w of theencapsulated compounded composition. In an aspect, the anti-bacterialagent can comprise about 25% w/w of the encapsulated compoundedcomposition.

In an aspect, the anti-fungal agent can comprise from about 10% to about40% w/w of the encapsulated compounded composition. In an aspect, theanti-fungal agent can comprise from about 15% to about 35% w/w of theencapsulated compounded composition. In an aspect, the anti-fungal agentcan comprise from about 20% to about 30% w/w of the encapsulatedcompounded composition. In an aspect, the anti-fungal agent can compriseabout 25% w/w of the encapsulated compounded composition.

In an aspect, the ratio of the anti-bacterial agent to the anti-fungalagent in the encapsulated compounded composition can be from about 1:4to about 4:1. In an aspect, the ratio of the anti-bacterial agent to theanti-fungal agent can be about 1:1. In an aspect, the ratio of theanti-bacterial agent to the anti-fungal agent can be about 1.25:1. See,e.g., Table 1.

In an aspect, the anti-bacterial agent can comprise afenide, amikacin,amoxicillin, ampicillin, arsphenamine, azithromycin, azlocillin,aztreonam, bacampicillin, bacitracin, carbacephem (loracarbef),carbenicillin, cefaclor, cefadroxil, cefalotin, cefamandole, cefazolin,cefdinir, cefditoren, cefepime, cefixime, cefoperazone, cefotaxime,cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, ceftizoxime,ceftobiprole, ceftriaxone, cefuroxime, cephalexin, chloramphenicol,chlorhexidine, ciprofloxacin, clarithromycin, clavulanic acid,clindamycin, cloxacillin, colimycin, colistimethate teicoplanin,colistin, demeclocycline, dicloxacillin, dirithromycin, doripenem,doxycycline, efprozil, enoxacin, ertapenem, erythromycin, ethambutol,flucloxacillin, fosfomycin, furazolidone, gatifloxacin, geldanamycin,gentamicin, grepafloxacin, herbimycin, imipenem, isoniazid, kanamycin,levofloxacin, lincomycin, linezolid, lomefloxacin, meropenem,meticillin, metronidazole, mezlocillin, minocycline, mitomycin,moxifloxacin, mupirocin, nafcillin, neomycin, netilmicin,nitrofurantoin, norfloxacin, ofloxacin, oxacillin, oxytetracycline,paromomycin, penicillin G, penicillin V, piperacillin, pivmecillinam,platensimycin, polymyxin B, prontosil, pvampicillin, pyrazinamide,quinupristin/dalfopristin, rifampicin, rifampin, roxithromycin,sparfloxacin, spectinomycin, spiramycin, sulbactam, sulfacetamide,sulfamethizole, sulfamethoxazole, sulfanilimide, sulfisoxazole,sulphonamides, sultamicillin, telithromycin, tetracycline,thiamphenicol, ticarcillin, tobramycin, trimethoprim,trimethoprim-sulfamethoxazole, troleandomycin, trovafloxacin, or acombination thereof.

In an aspect, the anti-bacterial agent of a disclosed encapsulatedcompounded composition can comprise mupirocin. In an aspect, theanti-bacterial agent of a disclosed encapsulated compounded compositioncan comprise azithromycin.

In an aspect, the anti-fungal agent can comprise abafungin,albaconazole, amorolfin, amphotericin b, anidulafungin, bifonazole,butenafine, butoconazole, candicidin, caspofungin, ciclopirox,clotrimazole, econazole, fenticonazole, filipin, fluconazole,flucytosine, griseofulvin, haloprogin, hamycin, isavuconazole,isoconazole, itraconazole, ketoconazole, micafungin, miconazole,naftifine, natamycin, nystatin, omoconazole, oxiconazole, polygodial,posaconazole, ravuconazole, rimocidin, sertaconazole, sulconazole,terbinafine, terconazole, tioconazole, tolnaftate, undecylenic acid,voriconazole, or a combination thereof.

In an aspect, a disclosed encapsulated compounded composition cancomprise itraconazole. In an aspect, a disclosed encapsulated compoundedcomposition can comprise fluconazole. In an aspect, a disclosedencapsulated compounded composition can comprise nystatin.

In an aspect, a disclosed encapsulated compounded composition cancomprise mupirocin and itraconazole. In an aspect, a disclosedencapsulated compounded composition can comprise azithromycin andfluconazole. In an aspect, a disclosed encapsulated compoundedcomposition can comprise mupirocin and nystatin.

In an aspect, a disclosed capsule can comprise about 100 mg to about2000 mg of a compounded composition. For example, in an aspect, adisclosed capsule can comprise about 100 mg, about 150 mg, about 200 mg,about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 450 mg,about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700 mg,about 750, about 800 mg, about 850 mg, about 900 mg, about 950 mg, about1000 mg, about 1050 mg, about 1100 mg, about 1150 mg, about 1200 mg,about 1250 mg, about 1300 mg, about 1350 mg, about 1400 mg, about 1450mg, about 1500 mg, about 1550 mg, about 1600 mg, about 1650 mg, about1700 mg, about 1750 mg, about 1800 mg, about 1850 mg, about 1900 mg,about 1950 mg, or about 2000 mg of a disclosed compounded composition.

In an aspect, a disclosed encapsulated compounded composition cancomprise one or more additional anti-infective agents. In an aspect, theadditional anti-infective agent can be a dry powder. In an aspect, theadditional anti-infective agent can be an ointment. The additionalanti-infective agent can be pure or substantially pure. The additionalanti-infective agent can be obtained from a bulk source. In an aspect,the additional anti-infective agent can be an anti-bacterial agent.Anti-bacterial agents are known to the art and discussed supra. In anaspect, the additional anti-infective agent can be an anti-fungal agent.Anti-fungal agents are known to the art and discussed supra.

In an aspect, a disclosed encapsulated compounded composition cancomprise one or more excipients or additives. In an aspect, excipientsor additives include, but are not limited to, the following: solvents,surfactants, humectants, preservatives, flavorings, stabilizers(including antioxidants), binders, and colorants.

a. Mupirocin and/or Itraconazole

Disclosed herein is a capsule comprising a compounded composition,wherein the compounded composition comprises mupirocin and itraconazole.Disclosed herein is a capsule comprising a compounded compositioncomprising mupirocin, an anti-fungal agent, and an excipient base powdercomprising a blend of micronized xylitol and poloxamers. Disclosedherein is a capsule comprising a compounded composition comprising ananti-bacterial agent, itraconazole, and an excipient base powdercomprising a blend of micronized xylitol and poloxamers. Disclosedherein is a capsule comprising a compounded composition comprisingmupirocin, itraconazole, and an excipient base powder comprising a blendof micronized xylitol and poloxamers. Disclosed herein is a capsulecomprising a compounded composition comprising mupirocin, itraconazole,an excipient base powder comprising a blend of micronized xylitol andpoloxamers, and at least one additional anti-infective agent. Disclosedherein is a capsule comprising a compounded composition comprisingmupirocin, itraconazole, and Loxasperse™ excipient base powder.

b. Azithromycin and/or Fluconazole

Disclosed herein is a capsule comprising a compounded composition,wherein the compounded composition comprises azithromycin andfluconazole. Disclosed herein is a capsule comprising a compoundedcomposition comprising azithromycin, an anti-fungal agent, and anexcipient base powder comprising a blend of micronized xylitol andpoloxamers. Disclosed herein is a capsule comprising a compoundedcomposition comprising an antibacterial agent, fluconazole, and anexcipient base powder comprising a blend of micronized xylitol andpoloxamers. Disclosed herein is a capsule comprising a compoundedcomposition comprising azithromycin, fluconazole, and an excipient basepowder comprising a blend of micronized xylitol and poloxamers.Disclosed herein is a capsule comprising a compounded compositioncomprising azithromycin, fluconazole, an excipient base powdercomprising a blend of micronized xylitol and poloxamers, and at leastone additional anti-infective agent. Disclosed herein is a capsulecomprising a compounded composition comprising azithromycin,fluconazole, and Loxasperse™ excipient base powder.

c. Mupirocin and/or Nystatin

Disclosed herein is a capsule comprising a compounded composition,wherein the compounded composition comprises mupirocin and nystatin.Disclosed herein is a capsule comprising a compounded compositioncomprising mupirocin, an anti-fungal agent, and an excipient base powdercomprising a blend of micronized xylitol and poloxamers. Disclosedherein is a capsule comprising a compounded composition comprising ananti-bacterial agent, nystatin, and an excipient base powder comprisinga blend of micronized xylitol and poloxamers. Disclosed herein is acapsule comprising a compounded composition comprising mupirocin,nystatin, and an excipient base powder comprising a blend of micronizedxylitol and poloxamers. Disclosed herein is a capsule comprising acompounded composition comprising mupirocin, nystatin, an excipient basepowder comprising a blend of micronized xylitol and poloxamers, and atleast one additional anti-infective agent. Disclosed herein is a capsulecomprising a compounded composition comprising mupirocin, nystatin, andLoxasperse™ excipient base powder.

2. Capsules Comprising an Anti-Bacterial Agent

Disclosed herein is a capsule comprising an anti-bacterial agent.

In an aspect, the anti-bacterial agent can be a dry powder. In anaspect, the antibacterial agent can be an ointment. The anti-bacterialagent can be pure or substantially pure. The anti-bacterial agent can beobtained from a bulk source.

In an aspect, a disclosed capsule can comprise an excipient base powdercomprising a blend of micronized xylitol and poloxamers. In an aspect,the excipient base powder can comprise Loxasperse™ excipient basepowder. In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder and XyliFos™ excipient base powder. In an aspect,an excipient base powder can be obtained from a bulk source.

In an aspect, the anti-bacterial agent can comprise afenide, amikacin,amoxicillin, ampicillin, arsphenamine, azithromycin, azlocillin,aztreonam, bacampicillin, bacitracin, carbacephem (loracarbef),carbenicillin, cefaclor, cefadroxil, cefalotin, cefamandole, cefazolin,cefdinir, cefditoren, cefepime, cefixime, cefoperazone, cefotaxime,cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, ceftizoxime,ceftobiprole, ceftriaxone, cefuroxime, cephalexin, chloramphenicol,chlorhexidine, ciprofloxacin, clarithromycin, clavulanic acid,clindamycin, cloxacillin, colimycin, colistimethate teicoplanin,colistin, demeclocycline, dicloxacillin, dirithromycin, doripenem,doxycycline, efprozil, enoxacin, ertapenem, erythromycin, ethambutol,flucloxacillin, fosfomycin, furazolidone, gatifloxacin, geldanamycin,gentamicin, grepafloxacin, herbimycin, imipenem, isoniazid, kanamycin,levofloxacin, lincomycin, linezolid, lomefloxacin, meropenem,meticillin, metronidazole, mezlocillin, minocycline, mitomycin,moxifloxacin, mupirocin, nafcillin, neomycin, netilmicin,nitrofurantoin, norfloxacin, ofloxacin, oxacillin, oxytetracycline,paromomycin, penicillin G, penicillin V, piperacillin, pivmecillinam,platensimycin, polymyxin B, prontosil, pvampicillin, pyrazinamide,quinupristin/dalfopristin, rifampicin, rifampin, roxithromycin,sparfloxacin, spectinomycin, spiramycin, sulbactam, sulfacetamide,sulfamethizole, sulfamethoxazole, sulfanilimide, sulfisoxazole,sulphonamides, sultamicillin, telithromycin, tetracycline,thiamphenicol, ticarcillin, tobramycin, trimethoprim,trimethoprim-sulfamethoxazole, troleandomycin, trovafloxacin, or acombination thereof.

In an aspect, a disclosed capsule can comprise mupirocin. In an aspect,a disclosed capsule can comprise azithromycin.

In an aspect, a disclosed capsule can comprise about 100 mg to about2000 mg of a disclosed anti-bacterial agent. For example, in an aspect,a disclosed capsule can comprise about 100 mg, about 150 mg, about 200mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 450mg, about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700mg, about 750, about 800 mg, about 850 mg, about 900 mg, about 950 mg,about 1000 mg, about 1050 mg, about 1100 mg, about 1150 mg, about 1200mg, about 1250 mg, about 1300 mg, about 1350 mg, about 1400 mg, about1450 mg, about 1500 mg, about 1550 mg, about 1600 mg, about 1650 mg,about 1700 mg, about 1750 mg, about 1800 mg, about 1850 mg, about 1900mg, about 1950 mg, or about 2000 mg of a disclosed anti-bacterial agent.

For example, in an aspect, a disclosed capsule can comprise about 100 mgto about 1000 mg of mupirocin. In an aspect, a disclosed capsule cancomprise about 100 mg of mupirocin, about 150 mg of mupirocin, about 200mg of mupirocin, about 250 mg of mupirocin, about 300 mg of mupirocin,about 350 mg of mupirocin, about 400 mg of mupirocin, about 450 mg ofmupirocin, about 500 mg of mupirocin, about 550 mg of mupirocin, about600 mg of mupirocin, about 650 mg of mupirocin, about 700 mg ofmupirocin, about 750 mg of mupirocin, about 800 mg of mupirocin, about850 mg of mupirocin, about 900 mg of mupirocin, about 950 mg ofmupirocin, or about 1000 mg of mupirocin, or more of mupirocin.

For example, in an aspect, a disclosed capsule can comprise about 100 mgto about 1000 mg of azithromycin. In an aspect, a disclosed capsule cancomprise about 100 mg of azithromycin, about 150 mg of azithromycin,about 200 mg of azithromycin, about 250 mg of azithromycin, about 300 mgof azithromycin, about 350 mg of azithromycin, about 400 mg ofazithromycin, about 450 mg of azithromycin, about 500 mg ofazithromycin, about 550 mg of azithromycin, about 600 mg ofazithromycin, about 650 mg of azithromycin, about 700 mg ofazithromycin, about 750 mg of azithromycin, about 800 mg ofazithromycin, about 850 mg of azithromycin, about 900 mg ofazithromycin, about 950 mg of azithromycin, or about 1000 mg ofazithromycin, or more of azithromycin. In an aspect, a disclosed capsulecan comprise about 250 mg of azithromycin.

In an aspect, a disclosed capsule can comprise about 100 mg to about2000 mg of linezolid. For example, in an aspect, a disclosed capsule cancomprise about 100 mg, about 150 mg, about 200 mg, about 250 mg, about300 mg, about 350 mg, about 400 mg, about 450 mg, about 500 mg, about550 mg, about 600 mg, about 650 mg, about 700 mg, about 750, about 800mg, about 850 mg, about 900 mg, about 950 mg, about 1000 mg, about 1050mg, about 1100 mg, about 1150 mg, about 1200 mg, about 1250 mg, about1300 mg, about 1350 mg, about 1400 mg, about 1450 mg, about 1500 mg,about 1550 mg, about 1600 mg, about 1650 mg, about 1700 mg, about 1750mg, about 1800 mg, about 1850 mg, about 1900 mg, about 1950 mg, or about2000 mg of linezolid.

In an aspect, a disclosed capsule may comprise 100 mg to about 1000 mgof levofloxacin. In an aspect, a disclosed capsule can comprise about100 mg of levofloxacin, about 150 mg of levofloxacin, about 200 mg oflevofloxacin, about 250 mg of levofloxacin, about 300 mg oflevofloxacin, about 350 mg of levofloxacin, about 400 mg oflevofloxacin, about 450 mg of levofloxacin, about 500 mg oflevofloxacin, about 550 mg of levofloxacin, about 600 mg oflevofloxacin, about 650 mg of levofloxacin, about 700 mg oflevofloxacin, about 750 mg of levofloxacin, about 800 mg oflevofloxacin, about 850 mg of levofloxacin, about 900 mg oflevofloxacin, about 950 mg of levofloxacin, or about 1000 mg oflevofloxacin, or more of levofloxacin. In various embodiments, theencapsulated levofloxacin may comprise bulk powder or a fine groundpowder of ground levofloxacin tablets.

In an aspect, a disclosed capsule can comprise one or more excipients oradditives. In an aspect, excipients or additives include, but are notlimited to, the following: solvents, surfactants, humectants,preservatives, flavorings, stabilizers (including antioxidants),binders, and colorants.

Disclosed herein is a capsule comprising mupirocin. Disclosed herein isa capsule comprising azithromycin.

3. Capsules Comprising an Anti-Fungal Agent

Disclosed herein is a capsule comprising an anti-fungal agent. In anaspect, the anti-fungal agent can be a dry powder. In an aspect, theanti-fungal agent can be an ointment.

The anti-fungal agent can be pure or substantially pure. The anti-fungalagent can be obtained from a bulk source.

In an aspect, a disclosed capsule can comprise an excipient base powdercomprising a blend of micronized xylitol and poloxamers. In an aspect,the excipient base powder can comprise Loxasperse™ excipient basepowder. In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder and XyliFos™ excipient base powder. In an aspect,an excipient base powder can be obtained from a bulk source.

In an aspect, the anti-fungal agent can comprise abafungin,albaconazole, amorolfin, amphotericin b, anidulafungin, bifonazole,butenafine, butoconazole, candicidin, caspofungin, ciclopirox,clotrimazole, econazole, fenticonazole, filipin, fluconazole,flucytosine, griseofulvin, haloprogin, hamycin, isavuconazole,isoconazole, itraconazole, ketoconazole, micafungin, miconazole,naftifine, natamycin, nystatin, omoconazole, oxiconazole, polygodial,posaconazole, ravuconazole, rimocidin, sertaconazole, sulconazole,terbinafine, terconazole, tioconazole, tolnaftate, undecylenic acid,voriconazole, or a combination thereof.

In an aspect, a disclosed capsule can comprise itraconazole. In anaspect, a disclosed capsule can comprise fluconazole. In an aspect, adisclosed capsule can comprise nystatin.

For example, in an aspect, a disclosed capsule can comprise about 100 mgto about 1000 mg of itraconazole. In an aspect, a disclosed capsule cancomprise about 100 mg of itraconazole, about 150 mg of itraconazole,about 200 mg of itraconazole, about 250 mg of itraconazole, about 300 mgof itraconazole, about 350 mg of itraconazole, about 400 mg ofitraconazole, about 450 mg of itraconazole, about 500 mg ofitraconazole, about 550 mg of itraconazole, about 600 mg ofitraconazole, about 650 mg of itraconazole, about 700 mg ofitraconazole, about 750 mg of itraconazole, about 800 mg ofitraconazole, about 850 mg of itraconazole, about 900 mg ofitraconazole, about 950 mg of itraconazole, or about 1000 mg ofitraconazole, or more of itraconazole.

For example, in an aspect, a disclosed capsule can comprise about 100 mgto about 1000 mg of fluconazole. In an aspect, a disclosed capsule cancomprise about 100 mg of fluconazole, about 150 mg of fluconazole, about200 mg of fluconazole, about 250 mg of fluconazole, about 300 mg offluconazole, about 350 mg of fluconazole, about 400 mg of fluconazole,about 450 mg of fluconazole, about 500 mg of fluconazole, about 550 mgof fluconazole, about 600 mg of fluconazole, about 650 mg offluconazole, about 700 mg of fluconazole, about 750 mg of fluconazole,about 800 mg of fluconazole, about 850 mg of fluconazole, about 900 mgof fluconazole, about 950 mg of fluconazole, or about 1000 mg offluconazole, or more of fluconazole. In an aspect, a disclosed capsulecan comprise about 200 mg of fluconazole.

For example, in an aspect, a disclosed capsule can comprise about 100 mgto about 1000 mg of nystatin. In an aspect, a disclosed capsule cancomprise about 100 mg of nystatin, about 150 mg of nystatin, about 200mg of nystatin, about 250 mg of nystatin, about 300 mg of nystatin,about 350 mg of nystatin, about 400 mg of nystatin, about 450 mg ofnystatin, about 500 mg of nystatin, about 550 mg of nystatin, about 600mg of nystatin, about 650 mg of nystatin, about 700 mg of nystatin,about 750 mg of nystatin, about 800 mg of nystatin, about 850 mg offluconazole, about 900 mg of nystatin, about 950 mg of nystatin, orabout 1000 mg of nystatin, or more of nystatin.

In an aspect, a disclosed capsule can comprise one or more excipients oradditives. In an aspect, excipients or additives include, but are notlimited to, the following: solvents, surfactants, humectants,preservatives, flavorings, stabilizers (including antioxidants),binders, and colorants.

Disclosed herein is a capsule comprising itraconazole. Disclosed hereinis a capsule comprising fluconazole. Disclosed herein is a capsulecomprising nystatin.

D. Kits

1. Kits Comprising a Compounded Composition

Disclosed herein is a kit comprising a disclosed compounded composition.

Disclosed herein is a kit, comprising: one or more containers, eachcomprising a compounded composition, wherein the compounded compositioncan comprise a therapeutically effective amount of an anti-bacterialagent, a therapeutically effective amount of an anti-fungal agent, andan amount of an excipient base powder comprising a blend of micronizedxylitol and poloxamers.

In an aspect, the kit can comprise instructions for using the compoundedcomposition.

In an aspect, the kit can comprise a footbath. In an aspect, a footbathcan comprise a mechanical agitation agent to mechanically agitate theenclosed water, a heating agent to heat the enclosed water, or both.Mechanical agitation agents and/or means to agitate water within acompartment are known to the art. In an aspect, a mechanical agitationagent can be a motorized agitation agent. In an aspect, an agitationagent or an agitator can be coupled to both a motor and the footbath.Motors and agitators are known to the art. In an aspect, mechanicalagitation can serve to distribute the compounded composition throughoutthe water contained within the footbath. Heating agents and/or means toheat water in a compartment are known to the art.

In an aspect, the kit can comprise one or more funnels. In an aspect,the kit can comprise one or more mixing containers. In an aspect, thekit can comprise one or more scoops.

In an aspect, the kit can comprise a diluent for the compoundedcomposition. In an aspect, the diluent can comprise sodium hypochlorite.In an aspect, the diluent can comprise Dakin's solution.

In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder and XyliFos™ excipient basepowder. In an aspect, an excipient base powder can be obtained from abulk source.

In an aspect, the anti-bacterial agent can be a dry powder. In anaspect, the antibacterial agent can be an ointment. The anti-bacterialagent can be pure or substantially pure. The anti-bacterial agent can beobtained from a bulk source. In an aspect, the anti-fungal agent can bea dry powder. In an aspect, the anti-fungal agent can be an ointment.The anti-fungal agent can be pure or substantially pure. The anti-fungalagent can be obtained from a bulk source.

In an aspect, the anti-bacterial agent can comprise from about 10% toabout 40% w/w of the compounded composition. In an aspect, theanti-bacterial agent can comprise from about 15% to about 35% w/w of thecompounded composition. In an aspect, the anti-bacterial agent cancomprise from about 20% to about 30% w/w of the compounded composition.In an aspect, the anti-bacterial agent can comprise about 25% w/w of thecompounded composition.

In an aspect, the anti-fungal agent can comprise from about 10% to about40% w/w of the compounded composition. In an aspect, the anti-fungalagent can comprise from about 15% to about 35% w/w of the compoundedcomposition. In an aspect, the anti-fungal agent can comprise from about20% to about 30% w/w of the compounded composition. In an aspect, theanti-fungal agent can comprise about 25% w/w of the compoundedcomposition.

In an aspect, the ratio of the anti-bacterial agent to the anti-fungalagent in the compounded composition can be from about 1:4 to about 4:1.In an aspect, the ratio of the anti-bacterial agent to the anti-fungalagent can be about 1:1. In an aspect, the ratio of the antibacterialagent to the anti-fungal agent can be about 1:1.25. See, e.g., Table 1.

In an aspect, the anti-bacterial agent can comprise afenide, amikacin,amoxicillin, ampicillin, arsphenamine, azithromycin, azlocillin,aztreonam, bacampicillin, bacitracin, carbacephem (loracarbef),carbenicillin, cefaclor, cefadroxil, cefalotin, cefamandole, cefazolin,cefdinir, cefditoren, cefepime, cefixime, cefoperazone, cefotaxime,cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, ceftizoxime,ceftobiprole, ceftriaxone, cefuroxime, cephalexin, chloramphenicol,chlorhexidine, ciprofloxacin, clarithromycin, clavulanic acid,clindamycin, cloxacillin, colimycin, colistimethate teicoplanin,colistin, demeclocycline, dicloxacillin, dirithromycin, doripenem,doxycycline, efprozil, enoxacin, ertapenem, erythromycin, ethambutol,flucloxacillin, fosfomycin, furazolidone, gatifloxacin, geldanamycin,gentamicin, grepafloxacin, herbimycin, imipenem, isoniazid, kanamycin,levofloxacin, lincomycin, linezolid, lomefloxacin, meropenem,meticillin, metronidazole, mezlocillin, minocycline, mitomycin,moxifloxacin, mupirocin, nafcillin, neomycin, netilmicin,nitrofurantoin, norfloxacin, ofloxacin, oxacillin, oxytetracycline,paromomycin, penicillin G, penicillin V, piperacillin, pivmecillinam,platensimycin, polymyxin B, prontosil, pvampicillin, pyrazinamide,quinupristin/dalfopristin, rifampicin, rifampin, roxithromycin,sparfloxacin, spectinomycin, spiramycin, sulbactam, sulfacetamide,sulfamethizole, sulfamethoxazole, sulfanilimide, sulfisoxazole,sulphonamides, sultamicillin, telithromycin, tetracycline,thiamphenicol, ticarcillin, tobramycin, trimethoprim,trimethoprim-sulfamethoxazole, troleandomycin, trovafloxacin, or acombination thereof.

In an aspect of a disclosed kit, the compounded composition can comprisemupirocin.

In an aspect of a disclosed kit, the compounded composition can compriseazithromycin.

In an aspect, the anti-fungal agent can comprise abafungin,albaconazole, amorolfin, amphotericin b, anidulafungin, bifonazole,butenafine, butoconazole, candicidin, caspofungin, ciclopirox,clotrimazole, econazole, fenticonazole, filipin, fluconazole,flucytosine griseofulvin, haloprogin, hamycin, isavuconazole,isoconazole, itraconazole, ketoconazole, micafungin, miconazole,naftifine, natamycin, nystatin, omoconazole, oxiconazole, polygodial,posaconazole, ravuconazole, rimocidin, sertaconazole, sulconazole,terbinafine, terconazole, tioconazole, tolnaftate, undecylenic acid,voriconazole, or a combination thereof.

In an aspect of a disclosed kit, the compounded composition can compriseitraconazole. In an aspect of a disclosed kit, the compoundedcomposition can comprise fluconazole. In an aspect of a disclosed kit,the compounded composition can comprise nystatin.

In an aspect of a disclosed kit, the compounded composition can comprisemupirocin and itraconazole. In an aspect of a disclosed kit, thecompounded composition can comprise azithromycin and fluconazole. In anaspect of a disclosed kit, the compounded composition can comprisemupirocin and nystatin.

In an aspect, a disclosed kit can comprise one or one or more containersof one or more additional anti-infective agents. In an aspect of adisclosed kit, a compounded composition can comprise one or moreadditional anti-infective agents. In an aspect, the additionalanti-infective agent can be a dry powder. In an aspect, the additionalanti-infective agent can be an ointment. The additional anti-infectiveagent can be pure or substantially pure. The additional anti-infectiveagent can be obtained from a bulk source. In an aspect, the additionalanti-infective agent can be an anti-bacterial agent. Anti-bacterialagents are known to the art and discussed supra. In an aspect, theadditional anti-infective agent can be an anti-fungal agent. Anti-fungalagents are known to the art and discussed supra.

In an aspect, a disclosed kit can comprise a plurality of containers,each comprising a compounded composition comprising an anti-bacterialagent and an anti-fungal agent. In an aspect, a plurality can compriseabout 30 containers, or about 60 containers, or about 90 containers, ormore containers. In an aspect, a plurality can comprise 120 containersor more of the compounded composition. In an aspect, the kit cancomprise an amount that the skilled person considers a monthly supply ofthe compounded composition.

Disclosed herein is a kit, comprising: one or more containers, eachcomprising a compounded composition, wherein the compounded compositioncan comprise a therapeutically effective amount of an anti-bacterialagent, a therapeutically effective amount of an anti-fungal agent, andan excipient base powder comprising a blend of micronized xylitol andpoloxamers, and instructions for using the compounded composition.

In an aspect, the anti-bacterial agent can comprise mupirocin. In anaspect, the anti-fungal agent can comprise itraconazole. In an aspect ofa disclosed kit, the compounded composition can comprise mupirocin anditraconazole. In an aspect, the anti-bacterial agent can compriseazithromycin. In an aspect, the anti-fungal agent can comprisefluconazole. In an aspect of a disclosed kit, the compounded compositioncan comprise azithromycin and fluconazole. In an aspect, theanti-bacterial agent can comprise mupirocin. In an aspect, theanti-fungal agent can comprise nystatin. In an aspect of a disclosedkit, the compounded composition can comprise mupirocin and nystatin.

Disclosed herein is a kit, comprising: one or more containers, eachcomprising a compounded composition, wherein the compounded compositioncan comprise a therapeutically effective amount of an anti-bacterialagent, a therapeutically effective amount of an anti-fungal agent, andan excipient base powder comprising a blend of micronized xylitol andpoloxamers, a footbath, and instructions for using the compoundedcomposition.

In an aspect, the anti-bacterial agent can comprise mupirocin. In anaspect, the anti-fungal agent can comprise itraconazole. In an aspect ofa disclosed kit, the compounded composition can comprise mupirocin anditraconazole. In an aspect, the anti-bacterial agent can compriseazithromycin. In an aspect, the anti-fungal agent can comprisefluconazole. In an aspect of a disclosed kit, the compounded compositioncan comprise azithromycin and fluconazole. In an aspect, theanti-bacterial agent can comprise mupirocin. In an aspect, theanti-fungal agent can comprise nystatin. In an aspect of a disclosedkit, the compounded composition can comprise mupirocin and nystatin.

In an aspect, a kit for treating an infection, such as a foot infection,includes an antibacterial solution, antifungal solution, or both. Insome embodiments, the kit may also include a diluent. Antibacterial orantimicrobial solutions may be a commercial solutions. For example, thekit may include a commercial solution of clindamycin, erythromycin, orboth, such as a 1% clindamycin solution or a 2% erythromucin solution.In an aspect, the kit includes one or more 30 mL or 60 mL bottles of acommercially available 1% clindamycin solution. In an aspect, the kitincludes one or more 30 mL or 60 mL bottles of a commercially available2% erythromycin solution.

In an aspect, a kit for treating an infection comprises linezolid. In anaspect, the linezolid may include a bulk powder or a fine powder ofground linezolid tablets, or a linezolid solution such as a linezolidsolution for injection or infusion. In an aspect, the linezolid mayinclude ground linezolid 600 mg tablets. The powder may be encapsulatedalone or with other actives or excipients. The kit may includeinstructions for combining the levofloxacin with a diluent. In anaspect, the kit includes a suitable amount of diluent. Diluents mayinclude, for example, water, sterile water, sodium hydroxide, saline,Dakin's Solution, or sodium hypochlorite. The kit may include a bath,mixing container, or both.

In an aspect, a kit for treating an infection comprises levofloxacin. Inan aspect, the levofloxacin may include a bulk powder or a fine powderof ground levofloxacin tablets. In an aspect, the levofloxacin mayinclude levofloxacin oral solution, such as levofloxacin 125 mg/5 mL (25mg/mL) solution, or levofloxacin for injection. The kit may includeinstructions for combining the levofloxacin with a diluent. In anaspect, the kit includes a suitable amount of diluent. Diluents mayinclude, for example, water, sterile water, sodium hydroxide, saline,Dakin's Solution, or sodium hypochlorite. The kit may include a bath,mixing container, or both.

In an aspect, a kit for treating an infection, such as a foot infection,includes a compounded composition herein and an antibacterial solution,antifungal solution, or both, as also described herein. In someembodiments, the kit may also include a diluent.

a. Compounded Composition Comprising Mupirocin and/or Itraconazole

Disclosed herein is a kit, comprising: one or more containers, eachcomprising a compounded composition, wherein the compounded compositioncan comprise a therapeutically effective amount of mupirocin, atherapeutically effective amount of itraconazole, and an excipient basepowder comprising a blend of micronized xylitol and poloxamers.Disclosed herein is a kit, comprising: one or more containers, eachcomprising a compounded composition, wherein the compounded compositioncan comprise a therapeutically effective amount of mupirocin, atherapeutically effective amount of itraconazole, and an excipient basepowder comprising a blend of micronized xylitol and poloxamers, andinstructions for using the compounded composition. Disclosed herein is akit, comprising: one or more containers, each comprising a compoundedcomposition, wherein the compounded composition can comprise atherapeutically effective amount of mupirocin, a therapeuticallyeffective amount of itraconazole, and an excipient base powdercomprising a blend of micronized xylitol and poloxamers, a footbath, andinstructions for using the compounded composition. In an aspect, adisclosed kit can comprise a plurality of containers, each comprising acompounded composition comprising mupirocin and itraconazole. In anaspect, a plurality can comprise about 30 containers, or about 60containers, or about 90 containers, or more containers. In an aspect, aplurality can comprise 120 containers or more of the compoundedcomposition comprising mupirocin and itraconazole. In an aspect, the kitcan comprise an amount that the skilled person considers a monthlysupply of the compounded composition.

b. Compounded Composition Comprising Azithromycin and/or Fluconazole

Disclosed herein is a kit, comprising: one or more containers, eachcomprising a compounded composition, wherein the compounded compositioncan comprise a therapeutically effective amount of azithromycin, atherapeutically effective amount of fluconazole, and an excipient basepowder comprising a blend of micronized xylitol and poloxamers.Disclosed herein is a kit, comprising: one or more containers, eachcomprising a compounded composition, wherein the compounded compositioncan comprise a therapeutically effective amount of azithromycin, atherapeutically effective amount of fluconazole, and an excipient basepowder comprising a blend of micronized xylitol and poloxamers, andinstructions for using the compounded composition. Disclosed herein is akit, comprising: one or more containers, each comprising a compoundedcomposition, wherein the compounded composition can comprise atherapeutically effective amount of azithromycin, a therapeuticallyeffective amount of fluconazole, and an excipient base powder comprisinga blend of micronized xylitol and poloxamers, a footbath, andinstructions for using the compounded composition. In an aspect, the oneor more containers, each comprising a compounded composition comprisingazithromycin and fluconazole, can comprise about 30 containers, or about60 containers, or about 90 containers, or more containers. In an aspect,a disclosed kit can comprise 120 containers or more of the compoundedcomposition comprising azithromycin and fluconazole. In an aspect, thekit can comprise an amount that the skilled person considers a monthlysupply of the compounded composition comprising azithromycin andfluconazole.

c. Compounded Composition Comprising Mupirocin and/or Nystatin

Disclosed herein is a kit, comprising: one or more containers, eachcomprising a compounded composition, wherein the compounded compositioncan comprise a therapeutically effective amount of mupirocin, atherapeutically effective amount of nystatin, and an excipient basepowder comprising a blend of micronized xylitol and poloxamers.Disclosed herein is a kit, comprising: one or more containers, eachcomprising a compounded composition, wherein the compounded compositioncan comprise a therapeutically effective amount of mupirocin, atherapeutically effective amount of nystatin, and an excipient basepowder comprising a blend of micronized xylitol and poloxamers, andinstructions for using the compounded composition. Disclosed herein is akit, comprising: one or more containers, each comprising a compoundedcomposition, wherein the compounded composition can comprise atherapeutically effective amount of mupirocin, a therapeuticallyeffective amount of nystatin, and an excipient base powder comprising ablend of micronized xylitol and poloxamers, a footbath, and instructionsfor using the compounded composition. In an aspect, the one or morecontainers, each comprising a compounded composition comprisingmupirocin and nystatin, can comprise about 30 containers, or about 60containers, or about 90 containers, or more containers. In an aspect, adisclosed kit can comprise 120 containers or more of the compoundedcomposition comprising mupirocin and nystatin. In an aspect, the kit cancomprise an amount that the skilled person considers a monthly supply ofthe compounded composition comprising mupirocin and nystatin.

2. Kits Comprising an Anti-Bacterial Agent and an Anti-Fungal Agent

Disclosed herein is a kit comprising an anti-bacterial agent and ananti-fungal agent.

Disclosed herein is a kit, comprising: one or more containers comprisinga therapeutically effective amount of an anti-bacterial agent and one ormore containers comprising a therapeutically effective amount of ananti-fungal agent.

In an aspect, the kit can comprise instructions for using theanti-bacterial agent and the anti-fungal agent.

In an aspect, the kit can comprise a footbath. In an aspect, a footbathcan comprise a mechanical agitation agent to mechanically agitate theenclosed water, a heating agent to heat the enclosed water, or both.Mechanical agitation agents and/or means to agitate water within acompartment are known to the art. In an aspect, a mechanical agitationagent can be a motorized agitation agent. In an aspect, an agitationagent or an agitator can be coupled to both a motor and the footbath.Motors and agitators are known to the art. In an aspect, mechanicalagitation can serve to distribute the anti-bacterial agent and theanti-fungal agent or both throughout the water contained within thefootbath. Heating agents and/or means to heat water in a compartment areknown to the art.

In an aspect, the kit can comprise one or more funnels. In an aspect,the kit can comprise one or more mixing containers. In an aspect, thekit can comprise one or more scoops.

In an aspect, the kit can comprise a diluent for the anti-bacterialagent. In an aspect, the kit can comprise a diluent for the anti-fungalagent. In an aspect, the diluent can comprise sodium hypochlorite. In anaspect, the diluent can comprise Dakin's solution. In an aspect, thediluent for the anti-bacterial agent is the same as the diluent for theanti-fungal agent. In an aspect, the diluent for the anti-bacterialagent is different than the diluent for the anti-fungal agent.

In an aspect, a disclosed kit can comprise one or more containerscomprising an excipient base powder comprising a blend of micronizedxylitol and poloxamers. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder. In an aspect, the excipientbase powder can comprise Loxasperse™ excipient base powder and XyliFos™excipient base powder. In an aspect, an excipient base powder can beobtained from a bulk source.

In an aspect, the anti-bacterial agent can be a dry powder. In anaspect, the antibacterial agent can be an ointment. The anti-bacterialagent can be pure or substantially pure. The anti-bacterial agent can beobtained from a bulk source. In an aspect, the anti-fungal agent can bea dry powder. In an aspect, the anti-fungal agent can be an ointment.The anti-fungal agent can be pure or substantially pure. The anti-fungalagent can be obtained from a bulk source.

In an aspect, the amount of anti-bacterial agent used in a disclosed kitcompared to the amount of anti-fungal agent used can be from about 1:4to about 4:1. In an aspect, the amount of anti-bacterial agent used in adisclosed kit compared to the amount of anti-fungal agent used can beabout 1:1. In an aspect, the amount of anti-bacterial agent used in adisclosed kit compared to the amount of anti-fungal agent used can beabout 1.25:1.

In an aspect, the anti-bacterial agent in a disclosed kit can compriseafenide, amikacin, amoxicillin, ampicillin, arsphenamine, azithromycin,azlocillin, aztreonam, bacampicillin, bacitracin, carbacephem(loracarbef), carbenicillin, cefaclor, cefadroxil, cefalotin,cefamandole, cefazolin, cefdinir, cefditoren, cefepime, cefixime,cefoperazone, cefotaxime, cefoxitin, cefpodoxime, cefprozil,ceftazidime, ceftibuten, ceftizoxime, ceftobiprole, ceftriaxone,cefuroxime, cephalexin, chloramphenicol, chlorhexidine, ciprofloxacin,clarithromycin, clavulanic acid, clindamycin, cloxacillin, colimycin,colistimethate teicoplanin, colistin, demeclocycline, dicloxacillin,dirithromycin, doripenem, doxycycline, efprozil, enoxacin, ertapenem,erythromycin, ethambutol, flucloxacillin, fosfomycin, furazolidone,gatifloxacin, geldanamycin, gentamicin, grepafloxacin, herbimycin,imipenem, isoniazid, kanamycin, levofloxacin, lincomycin, linezolid,lomefloxacin, meropenem, meticillin, metronidazole, mezlocillin,minocycline, mitomycin, moxifloxacin, mupirocin, nafcillin, neomycin,netilmicin, nitrofurantoin, norfloxacin, ofloxacin, oxacillin,oxytetracycline, paromomycin, penicillin G, penicillin V, piperacillin,pivmecillinam, platensimycin, polymyxin B, prontosil, pvampicillin,pyrazinamide, quinupristin/dalfopristin, rifampicin, rifampin,roxithromycin, sparfloxacin, spectinomycin, spiramycin, sulbactam,sulfacetamide, sulfamethizole, sulfamethoxazole, sulfanilimide,sulfisoxazole, sulphonamides, sultamicillin, telithromycin,tetracycline, thiamphenicol, ticarcillin, tobramycin, trimethoprim,trimethoprim-sulfamethoxazole, troleandomycin, trovafloxacin, or acombination thereof.

In an aspect of a disclosed kit, the anti-bacterial agent can comprisemupirocin. In an aspect of a disclosed kit, the anti-bacterial agent cancomprise azithromycin.

In an aspect, the anti-fungal agent of a disclosed kit can compriseabafungin, albaconazole, amorolfin, amphotericin b, anidulafungin,bifonazole, butenafine, butoconazole, candicidin, caspofungin,ciclopirox, clotrimazole, econazole, fenticonazole, filipin,fluconazole, flucytosine, griseofulvin, haloprogin, hamycin,isavuconazole, isoconazole, itraconazole, ketoconazole, micafungin,miconazole, naftifine, natamycin, nystatin, omoconazole, oxiconazole,polygodial, posaconazole, ravuconazole, rimocidin, sertaconazole,sulconazole, terbinafine, terconazole, tioconazole, tolnaftate,undecylenic acid, voriconazole, or a combination thereof.

In an aspect of a disclosed kit, the anti-fungal agent can compriseitraconazole. In an aspect of a disclosed kit, the anti-fungal agent cancomprise fluconazole. In an aspect of a disclosed kit, the anti-fungalagent can comprise nystatin.

In an aspect, a disclosed kit can comprise mupirocin and itraconazole.In an aspect, a disclosed kit can comprise azithromycin and fluconazole.In an aspect, a disclosed kit can comprise mupirocin and nystatin.

In an aspect, a disclosed kit can comprise one or more containers, eachcomprising one or more additional anti-infective agents. In an aspect,the additional anti-infective agent can be a dry powder. In an aspect,the additional anti-infective agent can be an ointment. The additionalanti-infective agent can be pure or substantially pure. The additionalanti-infective agent can be obtained from a bulk source. In an aspect,the additional anti-infective agent can be an anti-bacterial agent.Anti-bacterial agents are known to the art and discussed supra. In anaspect, the additional anti-infective agent can be an anti-fungal agent.Anti-fungal agents are known to the art and discussed supra.

In an aspect, a disclosed kit can comprise a plurality of containers,each comprising an anti-bacterial agent. In an aspect, a plurality cancomprise about 30 containers, or about 60 containers, or about 90containers, or more containers. In an aspect, a plurality can comprise120 containers or more of the anti-bacterial agent. In an aspect, thekit can comprise an amount that the skilled person considers a monthlysupply of the anti-bacterial agent.

In an aspect, a disclosed kit can comprise a plurality of containers,each comprising an anti-fungal agent. In an aspect, a plurality cancomprise about 30 containers, or about 60 containers, or about 90containers, or more containers. In an aspect, a plurality can comprise120 containers or more of the anti-fungal agent. In an aspect, the kitcan comprise an amount that the skilled person considers a monthlysupply of the anti-fungal agent.

Disclosed herein is a kit, comprising: one or more containers comprisinga therapeutically effective amount of an anti-bacterial agent or one ormore containers comprising a therapeutically effective amount of ananti-fungal agent, a footbath, and instructions for using theanti-bacterial agent and the anti-fungal agent.

In an aspect, the anti-bacterial agent can comprise mupirocin. In anaspect, the anti-fungal agent can comprise itraconazole. In an aspect, adisclosed kit can comprise mupirocin and itraconazole. In an aspect, theanti-bacterial agent can comprise azithromycin. In an aspect, theanti-fungal agent can comprise fluconazole. In an aspect, a disclosedkit can comprise azithromycin and fluconazole. In an aspect, theanti-bacterial agent can comprise mupirocin. In an aspect, theanti-fungal agent can comprise nystatin. In an aspect, a disclosed kitcan comprise mupirocin and nystatin.

Disclosed herein is a kit, comprising: one or more containers comprisinga therapeutically effective amount of an anti-bacterial agent or one ormore containers comprising a therapeutically effective amount of ananti-fungal agent, a footbath, and instructions for using theanti-bacterial agent and the anti-fungal agent.

In an aspect, the anti-bacterial agent can comprise mupirocin. In anaspect, the anti-fungal agent can comprise itraconazole. In an aspect, adisclosed kit can comprise mupirocin and itraconazole. In an aspect, theanti-bacterial agent can comprise azithromycin. In an aspect, theanti-fungal agent can comprise fluconazole. In an aspect, a disclosedkit can comprise azithromycin and fluconazole. In an aspect, theanti-bacterial agent can comprise mupirocin. In an aspect, theanti-fungal agent can comprise nystatin. In an aspect, a disclosed kitcan comprise mupirocin and nystatin.

a. Mupirocin and/or Itraconazole

Disclosed herein is a kit, comprising: one or more containers comprisinga therapeutically effective amount of mupirocin and one or morecontainers comprising a therapeutically effective amount ofitraconazole. Disclosed herein is a kit, comprising: one or morecontainers comprising a therapeutically effective amount of mupirocinand one or more containers comprising a therapeutically effective amountof itraconazole, and instructions for using the mupirocin and theitraconazole.

In an aspect, the kit can comprise a footbath. In an aspect, a footbathcan comprise a mechanical agitation agent to mechanically agitate theenclosed water, a heating agent to heat the enclosed water, or both.Mechanical agitation agents and/or means to agitate water within acompartment are known to the art. In an aspect, a mechanical agitationagent can be a motorized agitation agent. In an aspect, an agitationagent or an agitator can be coupled to both a motor and the footbath.Motors and agitators are known to the art. In an aspect, mechanicalagitation can serve to distribute the mupirocin and the itraconazole orboth throughout the water contained within the footbath. Heating agentsand/or means to heat water in a compartment are known to the art.

In an aspect, the kit can comprise one or more funnels. In an aspect,the kit can comprise one or more mixing containers. In an aspect, thekit can comprise one or more scoops.

In an aspect, the kit can comprise a diluent for the mupirocin. In anaspect, the kit can comprise a diluent for the itraconazole. In anaspect, the diluent can comprise sodium hypochlorite. In an aspect, thediluent can comprise Dakin's solution. In an aspect, the diluent for themupirocin is the same as the diluent for the itraconazole. In an aspect,the diluent for the mupirocin is different than the diluent for theitraconazole.

In an aspect, a disclosed kit can comprise one or more containerscomprising an excipient base powder comprising a blend of micronizedxylitol and poloxamers. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder. In an aspect, the excipientbase powder can comprise Loxasperse™ excipient base powder and XyliFos™excipient base powder. In an aspect, an excipient base powder can beobtained from a bulk source.

In an aspect, the mupirocin can be a dry powder. In an aspect, themupirocin can be an ointment. The mupirocin can be pure or substantiallypure. The mupirocin can be obtained from a bulk source. In an aspect,the itraconazole can be a dry powder. In an aspect, the itraconazole canbe an ointment. The itraconazole can be pure or substantially pure. Theitraconazole can be obtained from a bulk source.

In an aspect, the amount of the mupirocin used in a disclosed kitcompared to the amount of the itraconazole used can be from about 1:4 toabout 4:1. In an aspect, the amount of the mupirocin used in a disclosedkit compared to the amount of the itraconazole used can be about 1:1. Inan aspect, the amount of the mupirocin used in a disclosed kit comparedto the amount of the itraconazole used can be about 1.25:1.

In an aspect, a disclosed kit can comprise one or more containerscomprising one or more additional anti-infective agents. In an aspect,the additional anti-infective agent can be a dry powder. In an aspect,the additional anti-infective agent can be an ointment. The additionalanti-infective agent can be pure or substantially pure. The additionalanti-infective agent can be obtained from a bulk source. In an aspect,the additional anti-infective agent can be an anti-bacterial agent.Anti-bacterial agents are known to the art and discussed supra. In anaspect, the additional anti-infective agent can be an anti-fungal agent.Anti-fungal agents are known to the art and discussed supra.

In an aspect, a disclosed kit can comprise a plurality containers of themupirocin. For example, in an aspect, a disclosed kit can comprise about30 containers of the mupirocin, or about 60 containers of the mupirocin,or about 90 containers of the mupirocin. In an aspect, a disclosed kitcan comprise 120 containers of the mupirocin. In an aspect, the kit cancomprise an amount that the skilled person considers a monthly supply ofthe mupirocin.

In an aspect, the kit can comprise a plurality of containers of theitraconazole. For example, in an aspect, a disclosed kit can compriseabout 30 containers of the itraconazole, or about 60 containers of theitraconazole, or about 90 containers of the itraconazole. In an aspect,a disclosed kit can comprise 120 containers or more of the itraconazole.In an aspect, the kit can comprise an amount that the skilled personconsiders a monthly supply of the itraconazole.

Disclosed herein is a kit, comprising: one or more containers comprisinga therapeutically effective amount of mupirocin, one or more containerscomprising a therapeutically effective amount of itraconazole, afootbath, and instructions for using the mupirocin and the itraconazole.Disclosed herein is a kit, comprising: one or more containers comprisinga therapeutically effective amount of mupirocin, one or more containerscomprising a therapeutically effective amount of itraconazole, afootbath, one or more scoops, one or more mixing containers, a diluent,and instructions for using the mupirocin and the itraconazole.

b. Azithromycin and/or Fluconazole

Disclosed herein is a kit, comprising: one or more containers comprisinga therapeutically effective amount of azithromycin and one or morecontainers comprising a therapeutically effective amount of fluconazole.Disclosed herein is a kit, comprising: one or more containers comprisinga therapeutically effective amount of azithromycin, one or morecontainers comprising a therapeutically effective amount of fluconazole,and instructions for using the mupirocin and the itraconazole.

In an aspect, the kit can comprise a footbath. In an aspect, a footbathcan comprise a mechanical agitation agent to mechanically agitate theenclosed water, a heating agent to heat the enclosed water, or both.Mechanical agitation agents and/or means to agitate water within acompartment are known to the art. In an aspect, a mechanical agitationagent can be a motorized agitation agent. In an aspect, an agitationagent or an agitator can be coupled to both a motor and the footbath.Motors and agitators are known to the art. In an aspect, mechanicalagitation can serve to distribute the azithromycin and the fluconazoleor both throughout the water contained within the footbath. Heatingagents and/or means to heat water in a compartment are known to the art.

In an aspect, the kit can comprise one or more funnels. In an aspect,the kit can comprise one or more mixing containers. In an aspect, thekit can comprise one or more scoops.

In an aspect, the kit can comprise a diluent for the azithromycin. In anaspect, the kit can comprise a diluent for the fluconazole. In anaspect, the diluent can comprise sodium hypochlorite. In an aspect, thediluent can comprise Dakin's solution. In an aspect, the diluent for theazithromycin is the same as the diluent for the fluconazole. In anaspect, the diluent for the azithromycin is different than the diluentfor the fluconazole.

In an aspect, a disclosed kit can comprise one or more containerscomprising an excipient base powder comprising a blend of micronizedxylitol and poloxamers. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder. In an aspect, the excipientbase powder can comprise Loxasperse™ excipient base powder and XyliFos™excipient base powder. In an aspect, an excipient base powder can beobtained from a bulk source.

In an aspect, the azithromycin can be a dry powder. In an aspect, theazithromycin can be an ointment. The azithromycin can be pure orsubstantially pure. The azithromycin can be obtained from a bulk source.In an aspect, the fluconazole can be a dry powder. In an aspect, thefluconazole can be an ointment. The fluconazole can be pure orsubstantially pure. The fluconazole can be obtained from a bulk source.

In an aspect, the amount of the azithromycin used in a disclosed kitcompared to the amount of the fluconazole used can be from about 1:4 toabout 4:1. In an aspect, the amount of the azithromycin used in adisclosed kit compared to the amount of the fluconazole used can beabout 1:1. In an aspect, the amount of the azithromycin used in adisclosed kit compared to the amount of the fluconazole used can beabout 1.25:1.

In an aspect, a disclosed kit can comprise one or more containerscomprising one or more additional anti-infective agents. In an aspect,the additional anti-infective agent can be a dry powder. In an aspect,the additional anti-infective agent can be an ointment. The additionalanti-infective agent can be pure or substantially pure. The additionalanti-infective agent can be obtained from a bulk source. In an aspect,the additional anti-infective agent can be an anti-bacterial agent.Anti-bacterial agents are known to the art and discussed supra. In anaspect, the additional anti-infective agent can be an anti-fungal agent.Anti-fungal agents are known to the art and discussed supra.

In an aspect, a disclosed kit can comprise a plurality containers of theazithromycin. For example, in an aspect, a disclosed kit can compriseabout 30 containers of the azithromycin, or about 60 containers of theazithromycin, or about 90 containers of the azithromycin. In an aspect,a disclosed kit can comprise 120 containers of the azithromycin. In anaspect, the kit can comprise an amount that the skilled person considersa monthly supply of the azithromycin.

In an aspect, the kit can comprise a plurality of containers of thefluconazole. For example, in an aspect, a disclosed kit can compriseabout 30 containers of the fluconazole, or about 60 containers of thefluconazole, or about 90 containers of the fluconazole. In an aspect, adisclosed kit can comprise 120 containers or more of the fluconazole. Inan aspect, the kit can comprise an amount that the skilled personconsiders a monthly supply of the fluconazole.

Disclosed herein is a kit, comprising: one or more containers comprisinga therapeutically effective amount of azithromycin, one or morecontainers comprising a therapeutically effective amount of fluconazole,a footbath, and instructions for using the mupirocin and theitraconazole.

Disclosed herein is a kit, comprising: one or more containers, eachcomprising a therapeutically effective amount of azithromycin, one ormore containers comprising a therapeutically effective amount offluconazole, a footbath, one or more scoops, one or more mixingcontainers, a diluent, and instructions for using the azithromycin andthe fluconazole.

c. Mupirocin and/or Nystatin

Disclosed herein is a kit, comprising: one or more containers or tubescomprising a therapeutically effective amount of mupirocin and one ormore containers comprising a therapeutically effective amount ofnystatin. Disclosed herein is a kit, comprising: one or more containersor tubes comprising a therapeutically effective amount of mupirocin, oneor more containers comprising a therapeutically effective amount ofnystatin, and instructions for using the mupirocin and the nystatin.

In an aspect, the kit can comprise a footbath. In an aspect, a footbathcan comprise a mechanical agitation agent to mechanically agitate theenclosed water, a heating agent to heat the enclosed water, or both.Mechanical agitation agents and/or means to agitate water within acompartment are known to the art. In an aspect, a mechanical agitationagent can be a motorized agitation agent. In an aspect, an agitationagent or an agitator can be coupled to both a motor and the footbath.Motors and agitators are known to the art. In an aspect, mechanicalagitation can serve to distribute the mupirocin and the nystatin or boththroughout the water contained within the footbath. Heating agentsand/or means to heat water in a compartment are known to the art.

In an aspect, the kit can comprise one or more funnels. In an aspect,the kit can comprise one or more mixing containers. In an aspect, thekit can comprise one or more scoops. In an aspect, the kit can compriseone or more keys.

In an aspect, the kit can comprise a diluent for the mupirocin. In anaspect, the kit can comprise a diluent for the nystatin. In an aspect,the diluent can comprise sodium hypochlorite. In an aspect, the diluentcan comprise Dakin's solution. In an aspect, the diluent for themupirocin is the same as the diluent for the nystatin. In an aspect, thediluent for the mupirocin is different than the diluent for thenystatin.

In an aspect, a disclosed kit can comprise one or more containerscomprising an excipient base powder comprising a blend of micronizedxylitol and poloxamers. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder. In an aspect, the excipientbase powder can comprise Loxasperse™ excipient base powder and XyliFos™excipient base powder. In an aspect, an excipient base powder can beobtained from a bulk source.

In an aspect, the mupirocin can be a dry powder. The mupirocin can bepure or substantially pure. In an aspect, the mupirocin can be obtainedfrom a bulk source. In an aspect, the mupirocin can be an ointment. Inan aspect, the mupirocin can be a 2% ointment. In an aspect, themupirocin can be provided in a tube. For example, in an aspect, themupirocin can be provided in a 22 gram tube. In an aspect, the nystatincan be a dry powder. In an aspect, the nystatin can be an ointment. Thenystatin can be pure or substantially pure. In an aspect, the nystatincan be obtained from a bulk source. In an aspect, the nystatin can beprovided in a container. For example, in an aspect, the nystatin can beprovided in 15 gram container.

In an aspect, the kit can comprise a plurality of containers or tubes ofmupirocin. For example, in an aspect, a disclosed kit can comprise about30 containers or tubes of mupirocin, or about 60 containers or tubes ofmupirocin, or about 90 containers or tubes of mupirocin. In an aspect, adisclosed kit can comprise 120 containers or tubes of mupirocin or more.In an aspect, the kit can comprise an amount that the skilled personconsiders a monthly supply of the mupirocin.

In an aspect, the kit can comprise a plurality of containers ofnystatin. For example, in an aspect, a disclosed kit can comprise about30 containers of nystatin, or about 60 containers of nystatin, or about90 containers of nystatin. In an aspect, a disclosed kit can comprise120 containers or more of nystatin. In an aspect, the kit can comprisean amount that the skilled person considers a monthly supply of thenystatin.

In an aspect, a disclosed kit can comprise one or more containerscomprising one or more additional anti-infective agents. In an aspect,the additional anti-infective agent can be a dry powder. In an aspect,the additional anti-infective agent can be an ointment. The additionalanti-infective agent can be pure or substantially pure. The additionalanti-infective agent can be obtained from a bulk source. In an aspect,the additional anti-infective agent can be an anti-bacterial agent.Anti-bacterial agents are known to the art and discussed supra. In anaspect, the additional anti-infective agent can be an anti-fungal agent.Anti-fungal agents are known to the art and discussed supra.

Disclosed herein is a kit, comprising: one or more containers or tubescomprising a therapeutically effective amount of mupirocin, one or morecontainers comprising a therapeutically effective amount of nystatin, afootbath, and instructions for using the mupirocin and the nystatin.Disclosed herein is a kit, comprising: one or more containers or tubescomprising a therapeutically effective amount of mupirocin, one or morecontainers comprising a therapeutically effective amount of nystatin, afootbath, one or more scoops, a mixing container, one or more keys, adiluent, and instructions for using the mupirocin, and the nystatin.

E. Methods of Making a Compounded Composition

Disclosed herein is a method of making a compounded compositioncomprising an anti-bacterial agent, an anti-fungal agent, andcombinations thereof. The disclosed methods may be beneficially executedto formulate any compounded composition herein.

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount of a firstanti-bacterial agent and a therapeutically effective amount of a secondanti-bacterial agent to make a homogenous compounded composition. Adisclosed compounded composition can comprise a dry powder formulationor can comprise an ointment.

In an aspect, the mixing can comprise using an electronic mortar andpestle (EMP). In an aspect, a disclosed method can comprise milling thehomogenous compounded composition (using, for example, a three-rollmill) Mixing and milling can be done according to standards known to theskilled person in the art.

In an aspect, a disclosed method can comprise obtaining the firstanti-bacterial agent, obtaining the second anti-bacterial agent, or acombination thereof. In an aspect, obtaining can comprise obtaining abulk source of the first anti-bacterial agent, obtaining a bulk sourceof the second anti-bacterial agent, or a combination thereof.

Anti-bacterial agents are known to the art and are discussed supra.

In an aspect, a disclosed compounded composition comprising a firstantibacterial agent and a second anti-bacterial agent can comprise fromabout 1.0% w/w to about 3.0% w/w of the first anti-bacterial agent. Inan aspect, a disclosed compounded composition comprising a firstanti-bacterial agent and a second anti-bacterial agent can compriseabout 1.6% w/w, or about 1.756% w/w, or about 1.77% w/w, or about 1.775%w/w, or about 1.8% w/w of the first anti-bacterial agent. In an aspect,a disclosed compounded composition comprising a first anti-bacterialagent and a second anti-bacterial agent can comprise from about 4.0% w/wto about 9.0% w/w or from about 6.0% w/w to about 8.0% w/w of the secondanti-bacterial agent.

In an aspect, a disclosed compounded composition comprising a firstanti-bacterial agent and a second anti-bacterial agent comprise about5.0% w/w or about 7.5% w/w of the second antibacterial agent.

In an aspect, a disclosed method can comprise mixing one or moreexcipients or additives with the compounded composition. In an aspect,excipients or additives include, but are not limited to, the following:solvents, surfactants, humectants, preservatives, flavorings,stabilizers (including antioxidants), binders, and colorants.

In an aspect, a disclosed method can comprise mixing a therapeuticallyeffective amount of one or more additional anti-infective agents withthe compounded composition. In an aspect, the additional anti-infectiveagent can be an anti-bacterial agent. Anti-bacterial agents are known tothe art and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra. In an aspect, a disclosed method can compriseobtaining the additional anti-infective agent. In an aspect, obtainingcan comprise obtaining a bulk source of the anti-infective agent.

In an aspect, a disclosed method can comprise packaging the compoundedcomposition into a container and sealing the container. In an aspect, acontainer can be a container disclosed herein, such as, for example, aplastic tube, a glass or non-glass vial, a syringe, etc. In an aspect, adisclosed method can comprise sterilizing the compounded composition.

In an aspect, a method of making a compounded composition comprisescombining an antibacterial agent and an antifungal agent. Theantibacterial agent may comprise doxycycline, tobramycin, ciprofloxacin,mupirocin, or combination thereof. The antifungal agent my compriseketoconazole. In one embodiment, the method comprises combiningdoxycycline, ciprofloxacin, mupirocin, and ketoconazole. In anotherembodiment, the method comprises combining doxycycline, tobramycin,mupirocin, and ketoconazole. The antibacterials or antifungals may beadded as pure powders or powders obtained from ground commercialtablets. In some such embodiments, the method comprises combining thelisted ingredients wherein at least one of the antibacterials orantifungals comprise a commercially available ointment. For example, themethod may comprise combining the mupirocin wherein the mupirocin is inthe form of a commercially available mupirocin ointment, such asmupirocin 2.0% ointment.

In an aspect, the method may comprise combining the antibacterial agentin any amount by weight described herein. For example, in variousembodiments, the doxycycline may be combined in an amount betweenapproximately 0.1% and approximately 10%, approximately 1% andapproximately 7%, approximately 2% and approximately 5% by weight of thecompounded composition; one of ciprofloxacin or tobramycin may becombined in an amount between approximately 0.1% and approximately 10%,approximately 1% and approximately 7%, approximately 2% andapproximately 5% by weight of the compounded composition; and themupirocin may be combined in an amount between approximately 0.1% andapproximately 10%, approximately 1% and approximately 7%, approximately1.5% and approximately 4% by weight of the compounded composition. Theantifungal agent may be combined in any amount by weight describedherein. For example, the ketoconazole may be combined in an amountbetween approximately 0.1% and approximately 10%, approximately 1% andapproximately 7%, approximately 2% and approximately 5% by weight of thecompounded composition.

In an aspect, the method may comprise combining an antibacterial agentdoxycycline in an amount approximately 2.5% by weight, ciprofloxacin inan amount approximately 2.5% by weight, and mupirocin in an amountapproximately 1.7% by weight; and an antifungal agent comprisingketoconazole in an amount approximately 2.5% by weight. In anotherembodiment, the method may comprise combining an antibacterial agentcomprising doxycycline in an amount approximately 2.5% by weight,tobramycin in an amount approximately 2.5% by weight, and mupirocin inan amount approximately 1.7% by weight; and an antifungal agentcomprising ketoconazole in an amount approximately 2.5% by weight.

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount of ananti-bacterial agent and a therapeutically effective amount of ananti-fungal agent with an excipient base powder comprising a blend ofmicronized xylitol and poloxamers to make a homogenous compoundedcomposition.

In an aspect, the compounded composition can be a dry powderformulation.

In an aspect, the anti-bacterial agent can be a dry powder. In anaspect, the antibacterial agent can be an ointment. The anti-bacterialagent can be pure or substantially pure. In an aspect, the anti-fungalagent can be a dry powder. In an aspect, the anti-fungal agent can be anointment. The anti-fungal agent can be pure or substantially pure. In anaspect, the method can comprise obtaining the anti-bacterial agent, theanti-fungal agent, the excipient base powder, or a combination thereof.In an aspect, obtaining the anti-bacterial agent, the anti-fungal agent,or the excipient base powder can comprise obtaining a bulk source of theanti-bacterial agent, a bulk source of the anti-fungal agent, a bulksource of the excipient base powder, or a combination thereof.

In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder and XyliFos™ excipient basepowder.

In an aspect, the anti-bacterial agent can comprise from about 10% toabout 40% w/w of the compounded composition. In an aspect, theanti-bacterial agent can comprise from about 15% to about 35% w/w of thecompounded composition. In an aspect, the anti-bacterial agent cancomprise from about 20% to about 30% w/w of the compounded composition.In an aspect, the anti-bacterial agent can comprise about 25% w/w of thecompounded composition.

In an aspect, the anti-fungal agent can comprise from about 10% to about40% w/w of the compounded composition. In an aspect, the anti-fungalagent can comprise from about 15% to about 35% w/w of the compoundedcomposition. In an aspect, the anti-fungal agent can comprise from about20% to about 30% w/w of the compounded composition. In an aspect, theanti-fungal agent can comprise about 25% w/w of the compoundedcomposition.

In an aspect, the ratio of the anti-bacterial agent to the anti-fungalagent in the compounded composition can be from about 1:4 to about 4:1.In an aspect, the ratio of the anti-bacterial agent to the anti-fungalagent can be about 1:1. In an aspect, the ratio of the antibacterialagent to the anti-fungal agent can be about 1.25:1. See, e.g., Table 2.

In an aspect, the anti-bacterial agent can comprise afenide, amikacin,amoxicillin, ampicillin, arsphenamine, azithromycin, azlocillin,aztreonam, bacampicillin, bacitracin, carbacephem (loracarbef),carbenicillin, cefaclor, cefadroxil, cefalotin, cefamandole, cefazolin,cefdinir, cefditoren, cefepime, cefixime, cefoperazone, cefotaxime,cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, ceftizoxime,ceftobiprole, ceftriaxone, cefuroxime, cephalexin, chloramphenicol,chlorhexidine, ciprofloxacin, clarithromycin, clavulanic acid,clindamycin, cloxacillin, colimycin, colistimethate teicoplanin,colistin, demeclocycline, dicloxacillin, dirithromycin, doripenem,doxycycline, efprozil, enoxacin, ertapenem, erythromycin, ethambutol,flucloxacillin, fosfomycin, furazolidone, gatifloxacin, geldanamycin,gentamicin, grepafloxacin, herbimycin, imipenem, isoniazid, kanamycin,levofloxacin, lincomycin, linezolid, lomefloxacin, meropenem,meticillin, metronidazole, mezlocillin, minocycline, mitomycin,moxifloxacin, mupirocin, nafcillin, neomycin, netilmicin,nitrofurantoin, norfloxacin, ofloxacin, oxacillin, oxytetracycline,paromomycin, penicillin G, penicillin V, piperacillin, pivmecillinam,platensimycin, polymyxin B, prontosil, pvampicillin, pyrazinamide,quinupristin/dalfopristin, rifampicin, rifampin, roxithromycin,sparfloxacin, spectinomycin, spiramycin, sulbactam, sulfacetamide,sulfamethizole, sulfamethoxazole, sulfanilimide, sulfisoxazole,sulphonamides, sultamicillin, telithromycin, tetracycline,thiamphenicol, ticarcillin, tobramycin, trimethoprim,trimethoprim-sulfamethoxazole, troleandomycin, trovafloxacin, or acombination thereof.

In an aspect of a disclosed method, the anti-bacterial agent cancomprise mupirocin. In an aspect of a disclosed method, theanti-bacterial agent can comprise azithromycin.

In an aspect, the anti-fungal agent can comprise abafungin,albaconazole, amorolfin, amphotericin b, anidulafungin, bifonazole,butenafine, butoconazole, candicidin, caspofungin, ciclopirox,clotrimazole, econazole, fenticonazole, filipin, fluconazole,flucytosine, griseofulvin, haloprogin, hamycin, isavuconazole,isoconazole, itraconazole, ketoconazole, micafungin, miconazole,naftifine, natamycin, nystatin, omoconazole, oxiconazole, polygodial,posaconazole, ravuconazole, rimocidin, sertaconazole, sulconazole,terbinafine, terconazole, tioconazole, tolnaftate, undecylenic acid,voriconazole, or a combination thereof.

In an aspect of a disclosed method, the anti-fungal agent can compriseitraconazole. In an aspect of a disclosed method, the anti-fungal agentcan comprise fluconazole. In an aspect of a disclosed method, theanti-fungal agent can comprise nystatin.

In an aspect of a disclosed method, the anti-bacterial agent cancomprise mupirocin and the anti-fungal agent can comprise itraconazole.In an aspect of a disclosed method, the anti-bacterial agent cancomprise azithromycin and the anti-fungal agent can comprisefluconazole. In an aspect of a disclosed method, the anti-bacterialagent can comprise mupirocin and the anti-fungal agent can comprisenystatin.

In an aspect, the method can comprise mixing a therapeutically effectiveamount of an additional anti-infective agent with the compoundedcomposition. In an aspect, the additional anti-infective agent can be adry powder. In an aspect, the additional anti-infective agent can be anointment. The additional anti-infective can be pure or substantiallypure. The additional anti-infective agent can be obtained from a bulksource.

In an aspect, additional the anti-infective agent can be ananti-bacterial agent. Anti-bacterial agents are known to the art anddiscussed supra. In an aspect, the additional anti-infective agent canbe an anti-fungal agent. Anti-fungal agents are known to the art anddiscussed supra. In an aspect, the method can comprise obtaining theadditional anti-infective agent. In an aspect, obtaining the additionalanti-infective agent can comprise obtaining a bulk source of theanti-infective agent.

In an aspect, the method can comprise packaging the compoundedcomposition into a container and sealing the container. In an aspect,the method can comprise sterilizing the container comprising thecompounded composition.

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount of a firstanti-bacterial agent, a therapeutically effective amount of a secondanti-bacterial agent, and a therapeutically effective amount of ananti-fungal agent to make a homogenous compounded composition. Adisclosed compounded composition can comprise a dry powder formulationor can comprise an ointment.

In an aspect, the mixing can comprise using an electronic mortar andpestle (EMP). In an aspect, a disclosed method can comprise milling thehomogenous compounded composition (using, for example, a three-rollmill) Mixing and milling can be done according to standards known to theskilled person in the art.

In an aspect, a disclosed method can comprise obtaining the firstanti-bacterial agent, obtaining the second anti-bacterial agent,obtaining the anti-fungal agent, or a combination thereof. In an aspect,obtaining can comprise obtaining a bulk source of the firstanti-bacterial agent, obtaining a bulk source of the secondanti-bacterial agent, obtaining a bulk source of the anti-fungal agent,or a combination thereof.

Anti-bacterial agents are known to the art and are discussed supra.Anti-fungal agents are known to the art and are discussed supra.

In an aspect, a disclosed compounded composition comprising a firstantibacterial agent, a second anti-bacterial agent, and an anti-fungalagent can comprise from about 1.0% w/w to about 3.0% w/w of the firstanti-bacterial agent. In an aspect, a disclosed compounded compositioncomprising a first anti-bacterial agent, a second anti-bacterial agent,and an anti-fungal agent can comprise about 1.6% w/w, or about 1.756%w/w, or about 1.77% w/w, or about 1.775% w/w, or about 1.8% w/w of thefirst anti-bacterial agent. In an aspect, a disclosed compoundedcomposition comprising a first anti-bacterial agent, a secondantibacterial agent, and an anti-fungal agent can comprise from about2.0% w/w to about 9.0% w/w or from about 3.0% w/w to about 8.0% w/w ofthe second anti-bacterial agent. In an aspect, a disclosed compoundedcomposition comprising a first anti-bacterial agent, a secondantibacterial agent, and an anti-fungal agent can comprise about 2.5%w/w, about 5.0% w/w, or about 7.5% w/w of the second anti-bacterialagent. In an aspect, a disclosed compounded composition comprising afirst anti-bacterial agent, a second anti-bacterial agent, and ananti-fungal agent can comprise from about 2.0% w/w to about 9.0% w/w orfrom about 3.0% w/w to about 8.0% w/w of the anti-fungal agent. In anaspect, a disclosed compounded composition comprising a firstanti-bacterial agent, a second anti-bacterial agent, and an anti-fungalagent can comprise about 2.5% w/w, about 5.0% w/w, or about 7.5% w/w ofthe anti-fungal agent.

In an aspect, a disclosed method can comprise mixing one or moreexcipients or additives with the compounded composition. In an aspect,excipients or additives include, but are not limited to, the following:solvents, surfactants, humectants, preservatives, flavorings,stabilizers (including antioxidants), binders, and colorants.

In an aspect, a disclosed method can comprise mixing a therapeuticallyeffective amount of one or more additional anti-infective agents withthe compounded composition. In an aspect, the additional anti-infectiveagent can be an anti-bacterial agent. Anti-bacterial agents are known tothe art and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra. In an aspect, a disclosed method can compriseobtaining the additional anti-infective agent. In an aspect, obtainingcan comprise obtaining a bulk source of the anti-infective agent.

In an aspect, a disclosed method can comprise packaging the compoundedcomposition comprising a first anti-bacterial agent, a secondanti-bacterial agent, and an anti-fungal agent into a container andsealing the container. In an aspect, a container can be a containerdisclosed herein, such as, for example, a plastic tube, a glass ornon-glass vial, a syringe, etc. In an aspect, a disclosed method cancomprise sterilizing the compounded composition comprising a firstanti-bacterial agent, a second anti-bacterial agent, and an anti-fungalagent.

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin and a therapeutically effective amount of itraconazole with anexcipient base powder comprising a blend of micronized xylitol andpoloxamers to make a homogenous compounded composition.

In an aspect, the compounded composition can be a dry powderformulation.

In an aspect, the mupirocin can be a dry powder. In an aspect, themupirocin can be an ointment. The mupirocin can be pure or substantiallypure. In an aspect, the itraconazole can be a dry powder. In an aspect,the itraconazole can be an ointment. The itraconazole can be pure orsubstantially pure.

In an aspect, the method can comprise obtaining the mupirocin, theitraconazole, the excipient base powder, or a combination thereof. In anaspect, obtaining the mupirocin, the itraconazole, or the excipient basepowder can comprise obtaining a bulk source of the mupirocin, a bulksource of the itraconazole, a bulk source of the excipient base powder,or obtaining a combination thereof.

In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder and XyliFos™ excipient basepowder.

In an aspect, the mupirocin can comprise from about 10% to about 40% w/wof the compounded composition. In an aspect, the mupirocin can comprisefrom about 15% to about 35% w/w of the compounded composition. In anaspect, the mupirocin can comprise from about 20% to about 30% w/w ofthe compounded composition. In an aspect, the mupirocin can compriseabout 25% w/w of the compounded composition.

In an aspect, the itraconazole can comprise from about 10% to about 40%w/w of the compounded composition. In an aspect, the itraconazole cancomprise from about 15% to about 35% w/w of the compounded composition.In an aspect, the itraconazole can comprise from about 20% to about 30%w/w of the compounded composition. In an aspect, the itraconazole cancomprise about 25% w/w of the compounded composition.

In an aspect, the ratio of the mupirocin to the itraconazole in thecompounded composition can be from about 1:4 to about 4:1. In an aspect,the ratio of the mupirocin to the itraconazole can be about 1:1. In anaspect, the ratio of the mupirocin to the itraconazole can be about1.25:1. See, e.g., Table 2.

In an aspect, the method can comprise mixing a therapeutically effectiveamount of an additional anti-infective agent with the compoundedcomposition.

In an aspect, the additional anti-infective agent can be a dry powder.In an aspect, the additional anti-infective agent can be an ointment.The additional anti-infective agent can be pure or substantially pure.The additional anti-infective agent can be obtained from a bulk source.In an aspect, the additional anti-infective agent can be ananti-bacterial agent. Anti-bacterial agents are known to the art anddiscussed supra. In an aspect, the additional anti-infective agent canbe an anti-fungal agent. Anti-fungal agents are known to the art anddiscussed supra. In an aspect, the method can comprise obtaining theadditional anti-infective agent. In an aspect, obtaining the additionalanti-infective agent can comprise obtaining a bulk source of theanti-infective agent.

In an aspect, the method can comprise packaging the compoundedcomposition into a container and sealing the container. In an aspect,the method can comprise sterilizing the container comprising thecompounded composition comprising mupirocin and itraconazole.

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin and a therapeutically effective amount of an anti-fungal agentwith an excipient base powder comprising a blend of micronized xylitoland poloxamers to make a homogenous compounded composition.

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount of ananti-bacterial agent and a therapeutically effective amount ofitraconazole with an excipient base powder comprising a blend ofmicronized xylitol and poloxamers to make a homogenous compoundedcomposition.

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin and a therapeutically effective amount of an anti-bacterialagent to make a homogenous compounded composition. A disclosedcompounded composition can comprise a dry powder formulation or cancomprise an ointment.

In an aspect, a disclosed method can comprise obtaining the mupirocin,obtaining the anti-bacterial agent, or a combination thereof. In anaspect, obtaining can comprise obtaining a bulk source of the mupirocin,obtaining a bulk source of the anti-bacterial agent, or a combinationthereof.

In an aspect, the mixing can comprise using an electronic mortar andpestle (EMP). In an aspect, a disclosed method can comprise milling thehomogenous compounded composition (using, for example, a three-rollmill) Mixing and milling can be done according to standards known to theskilled person in the art.

Mupirocin is known to the art and is discussed supra. Anti-bacterialagents are known to the art and are discussed supra.

In an aspect, a disclosed compounded composition comprising mupirocinand an anti-bacterial agent can comprise from about 1.0% w/w to about3.0% w/w mupirocin. In an aspect, a disclosed compounded compositioncomprising mupirocin and an anti-bacterial agent can comprise about 1.6%w/w, or about 1.756% w/w, or about 1.77% w/w, or about 1.775% w/w, orabout 1.8% w/w mupirocin. In an aspect, a disclosed compoundedcomposition comprising mupirocin and an anti-bacterial agent cancomprise from about 4.0% w/w to about 9.0% w/w or from about 6.0% w/w toabout 8.0% w/w of the anti-bacterial agent. In an aspect, a disclosedcompounded composition comprising mupirocin and an anti-bacterial agentcan comprise about 5.0% w/w or about 7.5% w/w of the anti-bacterialagent.

In an aspect, a disclosed method can comprise mixing one or moreexcipients or additives with the compounded composition. In an aspect,excipients or additives include, but are not limited to, the following:solvents, surfactants, humectants, preservatives, flavorings,stabilizers (including antioxidants), binders, and colorants.

In an aspect, a disclosed method can comprise mixing a therapeuticallyeffective amount of one or more additional anti-infective agents withthe compounded composition. In an aspect, the additional anti-infectiveagent can be an anti-bacterial agent. Anti-bacterial agents are known tothe art and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra. In an aspect, a disclosed method can compriseobtaining the additional anti-infective agent. In an aspect, obtainingcan comprise obtaining a bulk source of the anti-infective agent.

In an aspect, a disclosed method can comprise packaging the compoundedcomposition comprising mupirocin and an anti-bacterial agent into acontainer and sealing the container. In an aspect, a container can be acontainer disclosed herein, such as, for example, a plastic tube, aglass or non-glass vial, a syringe, etc. In an aspect, a disclosedmethod comprise sterilizing the compounded composition comprisingmupirocin and an anti-bacterial agent.

In an aspect, a method of making a compounded composition comprising atreatment solution for contacting skin of a subject that is or may be orbecome infected with bacterium, as described herein, may include mixinglinezolid and a suitable amount of diluent. In various embodiments, thelinezolid may be obtained from commercially available bulk powder,crushed tablets, or linezolid solution as described above.

In an aspect, commercial linezolid tablets may be ground to a finepowder. In one example, a method of making a compounded composition forformulating a treatment solution comprises grinding to a fine powder oneor more linezolid tablets. The fine powder may be encapsulated asdescribed herein into capsules for subsequent mixing with diluent toformulate a suitable volume of treatment solution having the desireddosage strength by volume. For example, a treatment solution may includeabout 100 mg to about 2000 mg linezolid and as described elsewhere, suchas about 300 mg of linezolid per dose volume. Thus, about half theground powder obtained from a 600 mg linezolid tablet may be used toformulate a treatment solution, e.g., my mixing with diluent, orcompounded composition, e.g., by encapsulating alone or together withone or more addition actives or excipients as described herein,comprising about 300 mg linezolid. In one embodiment, the fine powdermay be encapsulated with an excipient base powder such as Loxasperse™for subsequent mixing with diluent to formulate a treatment solution,e.g., by opening of the capsule to release the powder for mixing withthe diluent. In one embodiment, the fine powder may be combined with theexcipient base powder without prior encapsulation, such as immediatelyfollowing grinding the tablet, and then mixed with diluent. An examplemethod to make a compounded composition comprising about 300 mglinezolid and excipient base powder comprises grinding one or morelinezolid 600 mg tablets to a fine powder. The average weight of alinezolid 600 mg tablet is about 916.5 mg. Thus, each dose capsuleshould contain 300 mg linezolid, which is equivalent to 0.5 linezolid600 mg tablets, which is equivalent to about 458.25 mg total weight oflinezolid 600 mg tablets. The ground fine powder may be encapsulatedwith excipient base powder such as Loxasperse™. Loxasperse™ may be addedto about 22.5% by weight, for example. In another example, about 0.225 gLoxasperse™ may be encapsulated with the about 458.25 mg linezolidtablet powder. Other amounts or ratios of linezolid to excipient may beused, such as those described elsewhere herein.

Further to the above, the compounded composition may comprise or bemixed with diluent to formulate a treatment solution. Such a treatmentsolution may be used for a bathing administration such as irrigation ofa skin area. As presented in the above example, a 300 mg linezolidtreatment solution for a bathing administration may include mixing abouthalf of a linezolid 600 mg tablet in a suitable amount of diluent tobath the skin area that is infected or could become infected. In oneexample, the amount of diluent used to formulate a treatment solutionfor use in a bathing administration to a foot or hand may be about 0.5liters and about 4 liters, such as between about 1 liter and about 2liters. Greater or lesser amounts may be used, for example, for largeror smaller skin areas of hands, feet, or other appendages.

In an aspect, a disclosed method can include formulating a treatmentsolution comprising combining linezolid powder, ground tablets, orsolution with a diluent, such as any diluent described herein, in amixing container or bathing container. The treatment solution, if in amixing container, may be added to the bathing container for contactingthe area to be treated. As described elsewhere herein, the treatmentsolution may be agitated. Similarly, the diluent may be added to thebathing container prior to or after the linezolid. Treating a footinfection in a footbath may comprise combining about 100 mg to about2000 mg, such as about 150 mg to about 1000 mg, about 150 mg to about750 mg, about 200 mg to about 600 mg, about 250 mg to about 500 mg,about 250 mg to about 400 mg, or about 300 mg to about 350 mg linezolid,e.g., pure powder, equivalent powder obtained from tablets, or solution,with diluent. The volume of diluent may be adjusted for the application.For example, a treatment solution for a bathing administration, such assubmerge or irrigation, may include between about 20 mL to about 4 L,such as about 30 mL to about 2 L, about 40 mL to about 1.5 L, about 40mL to about 1 L diluent.

In an aspect, a treatment solution comprising linezolid as describedherein may be topically administered to an outer body region. The outerbody region may include an outer body surface such as skin or adjoiningtissues, which in some instances may be exposed through broken skin. Theouter body surface may be infected or be suspected of being infected. Inone example, the treatment solution may be topically administered to askin area by contacting a skin area that is or is suspected to beinfected by a bacterium or fungus. Contacting may include bathing, e.g.,submerging or irrigating, the skin area. The treatment solution may becontacted to damaged or undamaged skin. For example, the treatmentsolution may contact broken skin and/or underlying tissue to bath thewounded area. Topical administration may include a bathingadministration, which may include submerging all or a portion of anouter body region or surface in the treatment solution, e.g., in a bathapplication or by irrigating all or a portion of the outer body region,or otherwise contacting all or a portion of the outer body region orsurface, such as by spraying, with the treatment solution in a sprayapplication. The outer body region may comprise skin such as a skinsurface a foot, hand, appendage, trunk, or portion thereof. Thetreatment solution may be topically administered, outside the body, fromthe external side of the body, to an affected body surface or underlyingtissue. For example, a foot, hand, or other body region may be placed ina bathing container or otherwise contacted with the treatment solutionin the bathing container for a suitable amount of time, e.g., 10 minutesor so, which may be repeated twice daily. In various embodiments,treating or preventing a bacterial infection may include topicallyadministering, outside of the body, linezolid to an affected body regionsuch as an outer or external body surface such as skin or underlyingexposed tissue, e.g., treatment of wounded or broken skin and underlyingtissue, as described herein.

In an aspect, a method of making a compounded composition comprising acompounded treatment solution for contacting skin of a subject that isor may be or become infected with bacterium, as described herein, mayinclude mixing levofloxacin and a suitable amount of diluent. In variousembodiments, the levofloxacin may be obtained from commerciallyavailable bulk powder, crushed tablets, oral solution, or levofloxacinfor injection, as described above.

In an aspect, levofloxacin oral solution may be mixed with diluent toformulate a suitable volume of treatment solution having the desireddosage strength by volume. For example, a treatment solution may include500 mg of levofloxacin per dose volume. To make a 40 mL dose volume ofsuch a treatment solution, 20 mL of levofloxacin oral solution, 125 mg/5mL (25 mg/mL), may be mixed with 20 mL of diluent. Such a treatmentsolution may be used for a bathing administration such as irrigation ofa skin area. In another example, a 500 mg levofloxacin treatmentsolution for a bathing administration may include mixing 20 mL of 25mg/mL levofloxacin oral solution in a suitable amount of diluent to baththe skin area that is infected or could become infected. In one example,the amount of diluent used to formulate a treatment solution for use ina bathing administration to a foot or hand may be about 0.5 liters andabout 4 liters, such as between about 1 liter and about 2 liters.Greater or lesser amounts may be used, for example, for larger orsmaller skin areas of hands, feet, or other appendages.

In an aspect, a disclosed method can include formulating a treatmentsolution comprising combining levofloxacin oral solution, 125 mg/5 mL(25 mg/mL), with a diluent, such as any diluent described herein, in amixing container or bathing container. The treatment solution, if in amixing container, may be added to the bathing container. Similarly, thediluent may be added to the bathing container prior to or after thelevofloxacin oral solution, 125 mg/5 mL (25 mg/mL). The treatmentsolution, if in a mixing container, may be added to the bathingcontainer for contacting the area to be treated. As described elsewhereherein, the treatment solution may be agitated. Treating a footinfection in a footbath may comprise combining about 10 mL to about 60mL, such as about 10 mL to about 50 mL, about 10 mL to about 40 mL,about 15 mL to about 40 mL, about 15 mL to about 35 mL, about 15 mL toabout 30 mL, or about 30 mL to about 60 mL levofloxacin oral solution,25 mg/mL with diluent. The volume of diluent may be adjusted for theapplication. For example, a treatment solution for a bathingadministration, such as submerge or irrigation, may include betweenabout 20 mL to about 4 L, such as about 30 mL to about 2 L, about 40 mLto about 1.5 L, about 40 mL to about 1 L diluent. In another aspect, thelevofloxacin may include a bulk powder or a fine powder of groundlevofloxacin tablets mixed with the diluent. The amount of groundlevofloxacin tablets needed may be determined by the methods disclosedherein. In one aspect, the levofloxacin may include levofloxacin forinjection.

In an aspect, a treatment solution comprising levofloxacin as describedherein may be topically administered to an outer body region. The outerbody region may include an outer body surface such as skin or adjoiningtissues, which in some instances may be exposed through broken skin. Theouter body surface may be infected or be suspected of being infected. Inone example, the treatment solution may be topically administered to askin area by contacting a skin area that is or is suspected to beinfected by a bacterium or fungus. Contacting may include bathing, e.g.,submerging or irrigating, the skin area. The treatment solution may becontacted to damaged or undamaged skin. For example, the treatmentsolution may contact broken skin, underlying tissue, or both to bath thewounded area. Topical administration may include a bathingadministration, which may include submerging all or a portion of anouter body region or surface in the treatment solution, e.g., in a bathapplication or by irrigating all or a portion of the outer body region,or otherwise contacting all or a portion of the outer body region orsurface, such as by spraying, with the treatment solution in a sprayapplication. The outer body region may comprise skin such as a skinsurface a foot, hand, appendage, trunk, or portion thereof. Thetreatment solution may be topically administered, outside the body, fromthe external side of the body, to an affected body surface or underlyingtissue. For example, a foot, hand, or other body region may be placed ina bathing container or otherwise contacted with the treatment solutionin the bathing container for a suitable amount of time, e.g., 10 minutesor so, which may be repeated twice daily. In various embodiments,treating or preventing a bacterial infection may include topicallyadministering, outside of the body, levofloxacin to an affected bodyregion such as an outer or external body surface such as skin orunderlying exposed tissue, e.g., treatment of wounded or broken skin andunderlying tissue, as described herein.

In various embodiments, treating or preventing a bacterial infection mayinclude topically administering, outside of the body, levofloxacin oralsolution, such as levofloxacin oral solution 125 mg/5 mL (25 mg/mL) toan outer body region such as an outer or external body surface such asskin or underlying exposed tissue, e.g., treatment of broken or woundedskin or underlying tissue. The topical administration may include abathing administration, which may include submerging all or a portion ofan affected body region in the treatment solution in a bath application,irrigating all or a portion of the affected body region with thetreatment solution in an irrigation application, or otherwise contactingall or a portion of the affected body region with the treatmentsolution, such as by spraying the treatment solution onto all or aportion of the affected body surface or underlying exposed tissue in aspray application. In some embodiments, levofloxacin 125 mg/5 mL (25mg/mL) solution, a solution intended for oral applications, may beadministered topically (outside the body) either through a bathfunctionality, a spray functionality, an irrigation functionality, orotherwise. In further embodiments, the levofloxacin oral solution 125mg/5 mL (25 mg/mL) may be combined with diluent to obtain a desiredadministration volume. For example, to make a topical treatment solutioncontaining 250 mg to 750 mg levofloxacin, about 10 mL to about 30 mL oflevofloxacin oral solution 125 mg/5 mL (25 mg/mL) may be combined withdiluent. Treatment may be repeated once or more daily as required.

1. Mupirocin and Tobramycin or a Salt Thereof

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin and a therapeutically effective amount of tobramycin or apharmaceutically acceptable salt thereof to make a homogenous compoundedcomposition. A disclosed compounded composition can comprise a drypowder formulation or can comprise an ointment.

In an aspect, a disclosed method can comprise obtaining the mupirocin,obtaining the tobramycin or a pharmaceutically acceptable salt thereof,or a combination thereof. In an aspect, obtaining can comprise obtaininga bulk source of the mupirocin, obtaining a bulk source of thetobramycin or a pharmaceutically acceptable salt thereof, or acombination thereof.

Mupirocin is known to the art and is discussed supra. Tobramycin as wellas pharmaceutically acceptable salts thereof are known to the art andare discussed supra.

In an aspect, a disclosed compounded composition comprising mupirocinand tobramycin or a salt thereof can comprise from about 1.0% w/w toabout 3.0% w/w mupirocin. In an aspect, a disclosed compoundedcomposition comprising mupirocin and tobramycin or a salt thereof cancomprise about 1.775% w/w mupirocin. In an aspect, a disclosedcompounded composition comprising mupirocin and tobramycin or a saltthereof can comprise from about 7.0% to about 9.0% w/w of tobramycin ora pharmaceutically acceptable salt thereof. In an aspect, a disclosedcompounded composition comprising mupirocin and tobramycin or a saltthereof can comprise about 7.5% w/w of tobramycin or a pharmaceuticallyacceptable salt thereof. In an aspect, a disclosed compoundedcomposition comprising mupirocin and tobramycin or a salt thereof cancomprise about 1.775% w/w mupirocin and about 7.5% w/w tobramycin or apharmaceutically acceptable salt thereof.

In an aspect, mupirocin can be added to a mixing container or extractedfrom a tube by attaching a key (e.g., a metal key) to an end of a tubeof mupirocin and sliding the key down the length of the tube towards theaperture of the tube, thereby forcing the contents of the tube into themixing container or out of the tube.

In an aspect, a disclosed method can comprise mixing one or moreexcipients or additives with the compounded composition. In an aspect,excipients or additives include, but are not limited to, the following:solvents, surfactants, humectants, preservatives, flavorings,stabilizers (including antioxidants), binders, and colorants.

In an aspect, a disclosed method can comprise mixing a therapeuticallyeffective amount of one or more additional anti-infective agents withthe compounded composition. In an aspect, the additional anti-infectiveagent can be an anti-bacterial agent. Anti-bacterial agents are known tothe art and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra. In an aspect, a disclosed method can compriseobtaining the additional anti-infective agent. In an aspect, obtainingcan comprise obtaining a bulk source of the anti-infective agent.

In an aspect, a disclosed method can comprise packaging the compoundedcomposition into a container and sealing the container. In an aspect, acontainer can be a container disclosed herein, such as, for example, aplastic tube, a glass or non-glass vial, a syringe, etc. In an aspect, adisclosed method can comprise sterilizing the compounded composition.

In an aspect, the mixing can comprise using an electronic mortar andpestle (EMP). In an aspect, a disclosed method can comprise milling thehomogenous compounded composition (using, for example, a three-rollmill) Mixing and milling can be done according to standards known to theskilled person in the art. In an aspect, to make the compoundedcomposition, mupirocin and tobramycin or a pharmaceutically acceptablesalt thereof can be combined and mixed together using, for example, anelectronic mortar and pestle (EMP). In an aspect, the EMP can be theUnguator 2100 or a similar device as recognized by the skilled person inthe art. The compounded composition can be mixed at least one time usingthe “normal” (or a comparable) setting. Then, the compounded compositioncan be milled to achieve the desired consistency using, for example, athree-roll mill (e.g., an Exakt 120S-450). The milled compoundedcomposition can then be mixed again using, for example, an EMP, and thendistributed into one or more containers, such as one or more containersdisclosed herein (e.g., a plastic tube, a glass or non-glass vial, asyringe, etc.).

Example 1

In an aspect, to make 1 g of the compounded composition, which has about1.775% w/w mupirocin and about 7.5% w/w tobramycin sulfate, about 0.8875g of mupirocin 2.0% ointment and about 0.1125 g of tobramycin sulfatefor injection USP powder can be combined and mixed together according toa method described above.

Table 1 provides the approximate amount of mupirocin and tobramycinsulfate needed to make various amounts of the compounded composition.

TABLE 1 MUPIROCIN AND TOBRAMYCIN SULFATE Compounded Mupirocin TobramycinSulfate Composition (in grams) (2.0% ointment) (for injection USPpowder) 1 0.8875 g 0.1125 g  4  3.55 g 0.45 g 8   7.1 g 0.90 g 2522.1875 g  2.8125 g  50 44.375 g 5.625 g  240  213.0 g 27.0 g 15001331.25 g  168.75 g 

As used in Example 1, the term “about” means a value falling within arange that is ±10% of the stated value. In an aspect, the skilled personcan combine 0.8875 g±10% mupirocin 2.0% ointment (e.g., from about0.79875 g-0.97625 g) and 0.1125 g±10% tobramycin sulfate for injectionUSP powder (e.g., from about 0.10125 g-0.12375 g) and mix togetheraccording to a method described above to make about 1.0 g±10% of thecompounded composition.

Example 2

In an aspect, to make 1 g of the compounded composition, which has about1.775% w/w mupirocin and about 7.5% w/w tobramycin, about 0.925 g ofmupirocin 2.0% ointment and about 0.075 g of pure or substantially puretobramycin powder can be combined and mixed together according to amethod described above.

Table 2 provides the approximate amount of mupirocin and pure orsubstantially pure tobramycin needed to make various amounts of thecompounded composition.

TABLE 2 MUPIROCIN AND PURE OR SUBSTANTIALLY PURE TOBRAMYCIN CompoundedMupirocin Tobramycin (pure/ Composition (in grams) (2.0% ointment)substantially pure dry) 1 0.925 g 0.075 g 4  3.7 g  0.3 g 8  7.4 g  0.6g 25 23.125 g  1.875 g 240 222.0 g  18.0 g 1500 1387.5 g  112.5 g

As used in Example 2, the term “about” means a value falling within arange that is ±10% of the stated value. In an aspect, the skilled personcan combine 0.925 g±10% mupirocin 2.0% ointment (e.g., from about 0.8325g-1.0175 g) and 0.075 g±10% pure or substantially pure dry tobramycinpowder (e.g., from about 0.0675 g-0.0825 g and mix together according toa method described above to make about 1.0 g±10% of the compoundedcomposition.

2. Mupirocin and Doxycycline or a Salt Thereof

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin and a therapeutically effective amount of doxycycline or apharmaceutically acceptable salt thereof to make a homogenous compoundedcomposition. A disclosed compounded composition can comprise a drypowder formulation or can comprise an ointment.

In an aspect, a disclosed method can comprise obtaining the mupirocin,obtaining the doxycycline or a pharmaceutically acceptable salt thereof,or a combination thereof. In an aspect, obtaining can comprise obtaininga bulk source of the mupirocin, obtaining a bulk source of thedoxycycline or a pharmaceutically acceptable salt thereof, or acombination thereof.

Mupirocin is known to the art and is discussed supra. Doxycycline aswell as pharmaceutically acceptable salts thereof are known to the artand are discussed supra.

In an aspect, a disclosed compounded composition comprising mupirocinand doxycycline or a salt thereof can comprise from about 1.0% w/w toabout 3.0% w/w mupirocin. In an aspect, a disclosed compoundedcomposition comprising mupirocin and doxycycline or a salt thereof cancomprise about 1.756% w/w mupirocin. In an aspect, a disclosedcompounded composition comprising mupirocin and doxycycline or a saltthereof can comprise from about 4.0% to about 6.0% w/w doxycycline or apharmaceutically acceptable salt thereof. In an aspect, a disclosedcompounded composition comprising mupirocin and doxycycline or a saltthereof can comprise about 5.0% w/w doxycycline or a pharmaceuticallyacceptable salt thereof. In an aspect, a disclosed compoundedcomposition comprising mupirocin and doxycycline or a salt thereof cancomprise about 1.756% w/w mupirocin and about 5.0% w/w doxycycline or apharmaceutically acceptable salt thereof.

In an aspect, the formula presented below can be used to identify theapproximate amount of powder from crushed doxycycline hyclate tabletsneeded for 1 g of the compounded composition: average tablet weight×% ofa tablet needed=amount of powder from crushed tablets needed.

In an aspect, the average weight of a doxycycline hyclate tablet can beabout 0.2435 g and can comprise about 100 mg of doxycycline. In anaspect, using the above-identified formula, the amount of powder fromcrushed doxycycline hyclate tablets can be determined to be about0.12175 g (or 121.75 mg).

${\underset{({0.2435\mspace{14mu} g})}{{average}\mspace{14mu}{tablet}\mspace{14mu}{weight}} \times \underset{({50\%})}{\%\mspace{14mu}{of}\mspace{14mu} a\mspace{14mu}{tablet}\mspace{14mu}{needed}}} = \underset{({0.12175\mspace{14mu} g})}{{amount}\mspace{14mu}{of}\mspace{14mu}{powder}\mspace{14mu}{from}\mspace{14mu}{crushed}\mspace{14mu}{tablets}\mspace{14mu}{needed}}$

In an aspect, mupirocin can be added to a mixing container or extractedfrom a tube by attaching a key (e.g., a metal key) to an end of a tubeof mupirocin and sliding the key down the length of the tube towards theaperture of the tube, thereby forcing the contents of the tube into themixing container or out of the tube.

In an aspect, a disclosed method can comprise mixing one or moreexcipients or additives with the compounded composition. In an aspect,excipients or additives include, but are not limited to, the following:solvents, surfactants, humectants, preservatives, flavorings,stabilizers (including antioxidants), binders, and colorants.

In an aspect, a disclosed method can comprise mixing a therapeuticallyeffective amount of one or more additional anti-infective agents withthe compounded composition. In an aspect, the additional anti-infectiveagent can be an anti-bacterial agent. Anti-bacterial agents are known tothe art and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra. In an aspect, a disclosed method can compriseobtaining the additional anti-infective agent. In an aspect, obtainingcan comprise obtaining a bulk source of the anti-infective agent.

In an aspect, a disclosed method can comprise packaging the compoundedcomposition comprising mupirocin and doxycycline or a salt thereof intoa container and sealing the container. In an aspect, a container can bea container disclosed herein, such as, for example, a plastic tube, aglass or non-glass vial, a syringe, etc. In an aspect, a disclosedmethod can comprise sterilizing the compounded composition comprisingmupirocin and doxycycline or a salt thereof.

In an aspect, the mixing can comprise using an electronic mortar andpestle (EMP). In an aspect, a disclosed method can comprise milling thehomogenous compounded composition (using, for example, a three-rollmill) Mixing and milling can be done according to standards known to theskilled person in the art. In an aspect, to make the compoundedcomposition, mupirocin and doxycycline or a pharmaceutically acceptablesalt thereof can be combined and mixed together using, for example, anelectronic mortar and pestle (EMP). In an aspect, the EMP can be theUnguator 2100 or a similar device as recognized by the skilled person inthe art. The compounded composition can be mixed at least one time usingthe “normal” (or a comparable) setting. Then, the compounded compositioncan be milled to achieve the desired consistency using, for example, athree-roll mill (e.g., an Exakt 120S-450). The milled compoundedcomposition can then be mixed again using, for example, an EMP, and thendistributed into one or more containers, such as one or more containersdisclosed herein (e.g., a plastic tube, a glass or non-glass vial, asyringe, etc.).

Example 3

In an aspect, to make 1 g of the compounded composition, which has about5.0% mupirocin and about 1.756% doxycycline or a pharmaceuticallyacceptable salt thereof, about 0.8782 g of mupirocin 2.0% ointment andabout 0.12175 g of powder from crushed doxycycline hyclate tablets canbe combined and mixed together according to a method described above.

Table 3 provides the approximate amount of mupirocin and doxycyclinehyclate needed to make various amounts of the compounded composition.

TABLE 3 MUPIROCIN AND DOXYCYCLINE HYCLATE Doxycycline Hyclate CompoundedComposition Mupirocin (powder from crushed (in grams) (2.0% ointment)tablets) 1 0.8782 g 0.12175 g  4 3.5128 g 0.487 g 8 7.0256 g 0.974 g 2521.955 g 3.04375 g  50  43.91 g 6.0875 g  240 210.768 g  29.22 g

As used in Example 3, the term “about” means a value falling within arange that is ±10% of the stated value. In an aspect, the skilled personcan combine 0.8782 g±10% mupirocin 2.0% ointment (e.g., from about0.79038 g-0.96602 g) and 0.12175 g±10% powder from crushed doxycyclinehyclate tablets (e.g., from about 0.109575 g-0.133925 g) and mixtogether according to a method described above to make about 1.0 g±10%of the compounded composition.

Example 4

In an aspect, to make 1 g of the compounded composition, which has about5.0% mupirocin and about 1.756% doxycycline, about 0.950 g of mupirocin2.0% ointment and about 0.050 g of pure or substantially puredoxycycline powder can be combined and mixed together according to amethod described above.

Table 4 provides the approximate amount of mupirocin and pure orsubstantially pure doxycycline needed to make various amounts of thecompounded composition.

TABLE 4 MUPIROCIN AND PURE OR SUBSTANTIALLY PURE DOXYCYCLINE DoxycyclineCompounded Composition Mupirocin (pure/substantially pure (in grams)(2.0% ointment) dry powder) 1 0.950 g 0.050 g  4  3.8 g  0.2 g 8  7.6 g 0.4 g 25 23.75 g 1.25 g 50  47.5 g  2.5 g 240 228.0 g 12.0 g 15001425.0 g  75.0 g

As used in Example 4, the term “about” means a value falling within arange that is ±10% of the stated value. In an aspect, the skilled personcan combine 0.950 g±10% mupirocin 2.0% ointment (e.g., from about 0.855g-1.045 g) and 0.050 g±10% pure or substantially pure doxycycline drypowder (e.g., from about 0.045 g-0.055 g) and mix together according toa method described above to make about 1.0 g±10% of the compoundedcomposition.

3. Mupirocin and Ciprofloxacin or a Salt Thereof

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin and a therapeutically effective amount of ciprofloxacin or apharmaceutically acceptable salt thereof to make a homogenous compoundedcomposition. A disclosed compounded composition can comprise a drypowder formulation or can comprise an ointment.

In an aspect, a disclosed method can comprise obtaining the mupirocin,obtaining the ciprofloxacin or a pharmaceutically acceptable saltthereof, or a combination thereof. In an aspect, obtaining can compriseobtaining a bulk source of the mupirocin, obtaining a bulk source ofciprofloxacin or a pharmaceutically acceptable salt thereof, or acombination thereof.

Mupirocin is known to the art and is discussed supra. Ciprofloxacin aswell as pharmaceutically acceptable salts thereof are known to the artand are discussed supra.

In an aspect, a disclosed compounded composition comprising mupirocinand ciprofloxacin or salt thereof can comprise from about 1.0% w/w toabout 3.0% w/w, from about 1.2% w/w to about 2.5% w/w, from about 1.4%w/w to about 2.3% w/w, from about 1.4% w/w to about 2.2% w/w, from about1.5% w/w to about 2.1% w/w, from about 1.6% w/w to about 2.0% w/w, fromabout 1.7% w/w to about 2.0% w/w, or from about 1.8% w/w to about 2.0%w/w mupirocin. In an aspect, a disclosed compounded compositioncomprising mupirocin and ciprofloxacin or salt thereof can comprise fromabout 1.0% w/w to about 5.0% w/w, from about 1.0% w/w to about 3.0% w/w,or from about 1.5% w/w to about 2.5% w/w ciprofloxacin or apharmaceutically acceptable thereof. In an aspect, a disclosedcompounded composition comprising mupirocin and ciprofloxacin or saltthereof can comprise from about 1.8% w/w to about 2.0% w/w mupirocin andfrom about 1.0% w/w to about 3.0% w/w ciprofloxacin or apharmaceutically acceptable thereof. In an aspect, a disclosedcompounded composition comprising mupirocin and ciprofloxacin or saltthereof can comprise about 1.95% w/w mupirocin and about 2.0% w/wciprofloxacin or a pharmaceutically acceptable salt thereof.

In an aspect, mupirocin can be added to a mixing container or extractedfrom a tube by attaching a key (e.g., a metal key) to an end of a tubeof mupirocin and sliding the key down the length of the tube towards theaperture of the tube, thereby forcing the contents of the tube into themixing container or out of the tube.

In an aspect, a disclosed method can comprise mixing one or moreexcipients or additives with the compounded composition. In an aspect,excipients or additives include, but are not limited to, the following:solvents, surfactants, humectants, preservatives, flavorings,stabilizers (including antioxidants), binders, and colorants.

In an aspect, a disclosed method can comprise mixing a therapeuticallyeffective amount of one or more additional anti-infective agents withthe compounded composition. In an aspect, the additional anti-infectiveagent can be an anti-bacterial agent. Anti-bacterial agents are known tothe art and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra. In an aspect, a disclosed method can compriseobtaining the additional anti-infective agent. In an aspect, obtainingcan comprise obtaining a bulk source of the anti-infective agent.

In an aspect, a disclosed method can comprise packaging the compoundedcomposition comprising mupirocin and ciprofloxacin or salt thereof intoa container and sealing the container. In an aspect, a container can bea container disclosed herein, such as, for example, a plastic tube, aglass or non-glass vial, a syringe, etc. In an aspect, a disclosedmethod can comprise sterilizing the compounded composition comprisingmupirocin and ciprofloxacin or salt thereof.

In an aspect, the mixing can comprise using an electronic mortar andpestle (EMP). In an aspect, a disclosed method can comprise milling thehomogenous compounded composition (using, for example, a three-rollmill) Mixing and milling can be done according to standards known to theskilled person in the art. In an aspect, to make the compoundedcomposition, mupirocin and ciprofloxacin or a pharmaceuticallyacceptable salt thereof can be combined and mixed together using, forexample, an electronic mortar and pestle (EMP). In an aspect, the EMPcan be the Unguator 2100 or a similar device as recognized by theskilled person in the art. The compounded composition can be mixed atleast one time using the “normal” (or a comparable) setting. Then, thecompounded composition can be milled to achieved the desired consistencyusing, for example, a three-roll mill (e.g., an Exakt 120S-450). Themilled compounded composition can then be mixed again using, forexample, an EMP, and then distributed into one or more containers, suchas one or more containers disclosed herein (e.g., a plastic tube, aglass or non-glass vial, a syringe, etc.).

Example 5

In an aspect, to make 1 g of the compounded composition, which has about1.95% w/w mupirocin and about 2.0% w/w ciprofloxacin, about 0.9767 g ofmupirocin 2.0% ointment and about 0.023288 g of ciprofloxacin HCl USPmonohydrate can be combined and mixed together according to a methoddescribed above.

Table 5 provides the approximate amount of mupirocin and ciprofloxacinhydrochloride needed to make various amounts of the compoundedcomposition.

TABLE 5 MUPIROCIN AND CIPROFLOXACIN HYDROCHLORIDE Compounded CompositionMupirocin Ciprofloxacin HCl (in grams) (2.0% ointment) (USP monohydrate)1 0.9767 g 0.023288 g  4 3.9068 g 0.093152 g  8 7.8136 g 0.186304 g  2524.4175 g  0.5822 g 50 48.835 g 1.1644 g 240 234.408 g  5.58912 g  15001465.05 g  34.932 g

As used in Example 5, the term “about” means a value falling within arange that is ±10% of the stated value. In an aspect, the skilled personcan combine 0.9767 g±10% mupirocin 2.0% ointment (e.g., from about0.87903 g-1.07437 g) and 0.02328 g±10% ciprofloxacin HCl monohydratepowder (e.g., from about 0.02095 g-0.025616 g) and mix togetheraccording to a method described above to make about 1.0 g±10% of thecompounded composition.

4. Mupirocin and Clindamycin or a Salt Thereof

Disclosed herein is method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin and a therapeutically effective amount of clindamycin or apharmaceutically acceptable salt thereof to make a homogenous compoundedcomposition. A disclosed compounded composition can comprise a drypowder formulation or can comprise an ointment.

In an aspect, a disclosed method can comprise obtaining the mupirocin,obtaining the clindamycin or a pharmaceutically acceptable salt thereof,or a combination thereof. In an aspect, obtaining can comprise obtaininga bulk source of the mupirocin, obtaining a bulk source of theclindamycin or a pharmaceutically acceptable salt thereof, or acombination thereof.

In an aspect, a disclosed compounded composition comprising mupirocinand clindamycin or a salt thereof can comprise from about 1.0% w/w toabout 3.0% w/w mupirocin. In an aspect, a disclosed compoundedcomposition comprising mupirocin and clindamycin or a salt thereof cancomprise about 1.88% w/w mupirocin. In an aspect, a disclosed compoundedcomposition comprising mupirocin and clindamycin or a salt thereof cancomprise from about 4.0% to about 6.0% w/w clindamycin or apharmaceutically acceptable salt thereof. In an aspect, a disclosedcompounded composition comprising mupirocin and clindamycin or a saltthereof can comprise about 5.0% w/w clindamycin or a pharmaceuticallyacceptable salt thereof. In an aspect, a disclosed compoundedcomposition comprising mupirocin and clindamycin or a salt thereof cancomprise about 1.88% w/w mupirocin and about 5.0% w/w clindamycin or apharmaceutically acceptable salt thereof.

In an aspect, mupirocin can be added to a mixing container or extractedfrom a tube by attaching a key (e.g., a metal key) to an end of a tubeof mupirocin and sliding the key down the length of the tube towards theaperture of the tube, thereby forcing the contents of the tube into themixing container or out of the tube.

In an aspect, a disclosed method can comprise mixing one or moreexcipients or additives with the compounded composition. In an aspect,excipients or additives include, but are not limited to, the following:solvents, surfactants, humectants, preservatives, flavorings,stabilizers (including antioxidants), binders, and colorants.

In an aspect, a disclosed method can comprise mixing a therapeuticallyeffective amount of one or more additional anti-infective agents withthe compounded composition. In an aspect, the additional anti-infectiveagent can be an anti-bacterial agent. Anti-bacterial agents are known tothe art and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra. In an aspect, a disclosed method can compriseobtaining the additional anti-infective agent. In an aspect, obtainingcan comprise obtaining a bulk source of the anti-infective agent.

In an aspect, a disclosed method can comprise packaging the compoundedcomposition comprising mupirocin and clindamycin or a salt thereof intoa container and sealing the container. In an aspect, a container can bea container disclosed herein, such as, for example, a plastic tube, aglass or non-glass vial, a syringe, etc. In an aspect, a disclosedmethod can comprise sterilizing the compounded composition comprisingmupirocin and clindamycin or a salt thereof.

In an aspect, the mixing can comprise using an electronic mortar andpestle (EMP). In an aspect, a disclosed method can comprise milling thehomogenous compounded composition (using, for example, a three-rollmill) Mixing and milling can be done according to standards known to theskilled person in the art. In an aspect, to make the compoundedcomposition, mupirocin and clindamycin or a pharmaceutically acceptablesalt thereof can be combined and mixed together using, for example, anelectronic mortar and pestle (EMP). In an aspect, the EMP can be theUnguator 2100 or a similar device as recognized by the skilled person inthe art. The compounded composition can be mixed at least one time usingthe “normal” (or a comparable) setting. Then, the compounded compositioncan be milled to achieved the desired consistency using, for example, athree-roll mill (e.g., an Exakt 120S-450). The milled compoundedcomposition can then be mixed again using, for example, an EMP, and thendistributed into one or more containers, such as one or more containersdisclosed herein (e.g., a plastic tube, a glass or non-glass vial, asyringe, etc.).

Example 6

In an aspect, to make about 1.0 g of the compounded composition, whichhas about 1.88% mupirocin and about 5.0% clindamycin or apharmaceutically acceptable salt thereof, about 0.940 g of mupirocin2.0% ointment and about 0.050 g of clindamycin hydrochloride USP powderbe combined and mixed together according to a method described above.

Table 6 provides the approximate amount of mupirocin and clindamycinhydrochloride needed to make various amounts of the compoundedcomposition.

TABLE 6 MUPIROCIN AND CLINDAMYCIN HYDROCHLORIDE Compounded CompositionMupirocin Clindamycin HCl (in grams) (2.0% ointment) (USP powder) 1 0.94g 0.050 g  -4  3.8 g 0.20 g -8  7.6 g 0.40 g 25 23.75 g  1.25 g -50 47.5g  2.5 g -240 228.0 g  12.0 g 1500 1425.0 g  75.0 g

As used in Example 6, the term “about” means a value falling within arange that is ±10% of the stated value. In an aspect, the skilled personcan combine 0.95 g±10% mupirocin 2.0% ointment (e.g., from about 0.855g-1.045 g) and 0.05 g±10% clindamycin HCl powder USP (e.g., from about0.045 g-0.055 g) and mix together according to a method described aboveto make about 1.0 g±10% of the compounded composition.

5. Mupirocin and an Anti-Fungal Agent

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin and a therapeutically effective amount of an anti-fungal agentto make a homogenous compounded composition. A disclosed compoundedcomposition can comprise a dry powder formulation or can comprise anointment.

In an aspect, mupirocin can be added to a mixing container or extractedfrom a tube by attaching a key (e.g., a metal key) to an end of a tubeof mupirocin and sliding the key down the length of the tube towards theaperture of the tube, thereby forcing the contents of the tube into themixing container or out of the tube.

In an aspect, a disclosed method can comprise obtaining the mupirocin,obtaining the anti-fungal agent, or a combination thereof. In an aspect,obtaining can comprise obtaining a bulk source of the mupirocin,obtaining a bulk source of the anti-fungal agent, or a combinationthereof.

Mupirocin is known to the art and is discussed supra. Anti-fungal agentsare known to the art and are discussed supra.

In an aspect, a disclosed compounded composition comprising mupirocinand an anti-fungal agent can comprise from about 1.0% w/w to about 3.0%w/w of the mupirocin. In an aspect, a disclosed compounded compositioncomprising mupirocin and an anti-fungal agent can comprise about 1.6%w/w, or about 1.756% w/w, or about 1.77% w/w, or about 1.775% w/w, orabout 1.8% w/w of the mupirocin. In an aspect, a disclosed compoundedcomposition comprising mupirocin and an anti-fungal agent from about4.0% w/w to about 9.0% w/w or from about 6.0% w/w to about 8.0% w/w ofthe anti-fungal agent. In an aspect, a disclosed compounded compositioncomprising mupirocin and an anti-fungal agent can comprise about 2.5%w/w, about 5.0% w/w, or about 7.5% w/w of the anti-fungal agent.

In an aspect, a disclosed method can comprise mixing one or moreexcipients or additives with the compounded composition. In an aspect,excipients or additives include, but are not limited to, the following:solvents, surfactants, humectants, preservatives, flavorings,stabilizers (including antioxidants), binders, and colorants.

In an aspect, a disclosed method can comprise mixing a therapeuticallyeffective amount of one or more additional anti-infective agents withthe compounded composition. In an aspect, the additional anti-infectiveagent can be an anti-bacterial agent. Anti-bacterial agents are known tothe art and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra. In an aspect, a disclosed method can compriseobtaining the additional anti-infective agent. In an aspect, obtainingcan comprise obtaining a bulk source of the anti-infective agent.

In an aspect, a disclosed method can comprise packaging the compoundedcomposition comprising mupirocin and an anti-fungal agent into acontainer and sealing the container. In an aspect, a container can be acontainer disclosed herein, such as, for example, a plastic tube, aglass or non-glass vial, a syringe, etc. In an aspect, a disclosedmethod can comprise sterilizing the compounded composition comprisingmupirocin and an anti-fungal agent.

In an aspect, the mixing can comprise using an electronic mortar andpestle (EMP). In an aspect, a disclosed method can comprise milling thehomogenous compounded composition (using, for example, a three-rollmill) Mixing and milling can be done according to standards known to theskilled person in the art.

6. Mupirocin and Ketoconazole

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin and a therapeutically effective amount of ketoconazole to makea homogenous compounded composition. A disclosed compounded compositioncan comprise a dry powder formulation or can comprise an ointment.

In an aspect, a disclosed method can comprise obtaining the mupirocin,obtaining the ketoconazole, or a combination thereof. In an aspect,obtaining can comprise obtaining a bulk source of the mupirocin,obtaining a bulk source of ketoconazole, or a combination thereof.

Mupirocin is known to the art and is discussed supra. Ketoconazole isknown to the art and is discussed supra.

In an aspect, a disclosed compounded composition comprising mupirocinand ketoconazole can comprise from about 1.0% w/w to about 3.0% w/wmupirocin. In an aspect, a disclosed compounded composition comprisingmupirocin and ketoconazole can comprise about 1.77% w/w mupirocin. In anaspect, a disclosed compounded composition comprising mupirocin andketoconazole can comprise from about 6.5% w/w to about 8.5% w/wketoconazole. In an aspect, a disclosed compounded compositioncomprising mupirocin and ketoconazole can comprise about 7.5% w/wketoconazole. In an aspect, a disclosed compounded compositioncomprising mupirocin and ketoconazole can comprise about 1.77% w/wmupirocin and about 7.5% w/w ketoconazole.

The formula presented below can be used to identify the approximateamount of powder from crushed ketoconazole tablets needed for 1 gram ofthe compounded composition: avg. tablet weight (g)×% of a tabletneeded=amt. of powder from crushed tablets needed (g)

In an aspect, the average weight of a ketoconazole tablet can be about0.310 grams and can comprise about 200 mg of ketoconazole. In an aspect,using the above-identified formula, the amount of powder from crushedketoconazole tablets can be determined to be about 0.11625 g (or 116.25mg).

${\underset{({0.310\mspace{14mu} g})}{{{avg}.\mspace{14mu}{tablet}}\mspace{14mu}{weight}} \times \underset{({37.5\%})}{\%\mspace{14mu}{of}\mspace{14mu} a\mspace{14mu}{tablet}\mspace{14mu}{needed}}} = \underset{({0.11625\mspace{14mu} g})}{{amount}\mspace{14mu}{of}\mspace{14mu}{powder}\mspace{14mu}{from}\mspace{14mu}{crushed}\mspace{14mu}{tablets}\mspace{14mu}{needed}}$

In an aspect, mupirocin can be added to a mixing container or extractedfrom a tube by attaching a key (e.g., a metal key) to an end of a tubeof mupirocin and sliding the key down the length of the tube towards theaperture of the tube, thereby forcing the contents of the tube into themixing container or out of the tube.

In an aspect, a disclosed method can comprise mixing one or moreexcipients or additives with the compounded composition. In an aspect,excipients or additives include, but are not limited to, the following:solvents, surfactants, humectants, preservatives, flavorings,stabilizers (including antioxidants), binders, and colorants.

In an aspect, a disclosed method can comprise mixing a therapeuticallyeffective amount of one or more additional anti-infective agents withthe compounded composition. In an aspect, the additional anti-infectiveagent can be an anti-bacterial agent. Anti-bacterial agents are known tothe art and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra. In an aspect, a disclosed method can compriseobtaining the additional anti-infective agent. In an aspect, obtainingcan comprise obtaining a bulk source of the anti-infective agent.

In an aspect, a disclosed method can comprise packaging the compoundedcomposition comprising mupirocin and ketoconazole into a container andsealing the container.

In an aspect, a container can be a container disclosed herein, such as,for example, a plastic tube, a glass or non-glass vial, a syringe, etc.In an aspect, a disclosed method can comprise sterilizing the compoundedcomposition comprising mupirocin and ketoconazole.

In an aspect, the mixing can comprise using an electronic mortar andpestle (EMP). In an aspect, a disclosed method can comprise milling thehomogenous compounded composition (using, for example, a three-rollmill) Mixing and milling can be done according to standards known to theskilled person in the art. In an aspect, to make the compoundedcomposition, mupirocin and ketoconazole can be combined and mixedtogether using, for example, an electronic mortar and pestle (EMP). Inan aspect, the EMP can be the Unguator 2100 or a similar device asrecognized by the skilled person in the art. The compounded compositioncan be mixed at least one time using the “normal” (or a comparable)setting. Then, the compounded composition can be milled to achieve thedesired consistency using, for example, a three-roll mill (e.g., anExakt 120S-450). The milled compounded composition can then be mixedagain using, for example, an EMP, and then distributed into one or morecontainers, such as one or more containers disclosed herein (e.g., aplastic tube, a glass or non-glass vial, a syringe, etc.).

Example 7

In an aspect, to make 1 g of the compounded composition, which has about1.77% w/w mupirocin and about 7.5% w/w ketoconazole, about 0.8838 g ofmupirocin 2.0% ointment and about 0.11625 g of powder from crushedketoconazole tablets can be combined and mixed together according to amethod described above.

Table 7 provides the approximate amount of mupirocin and ketoconazoleneeded to make various amounts of the compounded composition.

TABLE 7 MUPIROCIN AND KETOCONAZOLE Ketoconazole Compounded CompositionMupirocin (powder from crushed (in grams) (2.0% ointment) tablets) 10.8838 g 0.11625 g   4 3.5352 g 0.465 g  8 7.0704 g 0.93 g 25 22.095 g2.90625 g   50  44.19 g 5.8125 g  240 212.112 g  27.9 g

As used in Example 7, the term “about” means a value falling within arange that is ±10% of the stated value. In an aspect, the skilled personcan combine 0.8838 g±10% mupirocin 2.0% ointment (e.g., from about0.79542 g-0.97218 g) and 0.11625 g±10% powder from crushed ketoconazoletablets (e.g., from about 0.104625 g-0.127875 g) and mix togetheraccording to a method described above to make about 1.0 g±10% of thecompounded composition.

7. Mupirocin, an Anti-Bacterial Agent, and an Anti-Fungal Agent

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin, a therapeutically effective amount of an anti-bacterialagent, and a therapeutically effective amount of an anti-fungal agent tomake a homogenous compounded composition. A disclosed compoundedcomposition can comprise a dry powder formulation or can comprise anointment.

In an aspect, a disclosed method can comprise obtaining the mupirocin,obtaining the anti-bacterial agent, obtaining the anti-fungal agent, ora combination thereof. In an aspect, obtaining can comprise obtaining abulk source of the mupirocin, obtaining a bulk source of theanti-bacterial agent, obtaining a bulk source of the anti-fungal agent,or a combination thereof.

Mupirocin is known to the art and is discussed supra. Anti-bacterialagents are known to the art and are discussed supra. Anti-fungal agentsare known to the art and are discussed supra.

In an aspect, a disclosed compounded composition comprising mupirocin,an anti-bacterial agent, and an anti-fungal agent can comprise fromabout 1.0% w/w to about 3.0% w/w mupirocin. In an aspect, a disclosedcompounded composition comprising mupirocin, an anti-bacterial agent,and an anti-fungal agent can comprise about 1.6% w/w, or about 1.756%w/w, or about 1.77% w/w, or about 1.775% w/w, or about 1.8% w/wmupirocin. In an aspect, a disclosed compounded composition comprisingmupirocin, an anti-bacterial agent, and an anti-fungal agent cancomprise from about 4.0% w/w to about 9.0% w/w or from about 6.0% w/w toabout 8.0% w/w of the anti-bacterial agent. In an aspect, a disclosedcompounded composition comprising mupirocin, an anti-bacterial agent,and an anti-fungal agent can comprise about 5.0% w/w or about 7.5% w/wof the anti-bacterial agent. In an aspect, a disclosed compoundedcomposition comprising mupirocin, an anti-bacterial agent, and ananti-fungal agent can comprise from about 4.0% w/w to about 9.0% w/w orfrom about 6.0% w/w to about 8.0% w/w of the anti-fungal agent. In anaspect, a disclosed compounded composition comprising mupirocin, ananti-bacterial agent, and an anti-fungal agent can comprise about 5.0%w/w or about 7.5% w/w of the anti-fungal agent.

In an aspect, a disclosed method can comprise mixing one or moreexcipients or additives with the compounded composition. In an aspect,excipients or additives include, but are not limited to, the following:solvents, surfactants, humectants, preservatives, flavorings,stabilizers (including antioxidants), binders, and colorants.

In an aspect, a disclosed method can comprise mixing a therapeuticallyeffective amount of one or more additional anti-infective agents withthe compounded composition. In an aspect, the additional anti-infectiveagent can be an anti-bacterial agent. Anti-bacterial agents are known tothe art and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra. In an aspect, a disclosed method can compriseobtaining the additional anti-infective agent. In an aspect, obtainingcan comprise obtaining a bulk source of the anti-infective agent.

In an aspect, a disclosed method can comprise packaging the compoundedcomposition into a container and sealing the container. In an aspect, acontainer can be a container disclosed herein, such as, for example, aplastic tube, a glass or non-glass vial, a syringe, etc. In an aspect, adisclosed method can comprise sterilizing the compounded composition.

In an aspect, the mixing can comprise using an electronic mortar andpestle (EMP). In an aspect, a disclosed method can comprise milling thehomogenous compounded composition (using, for example, a three-rollmill) Mixing and milling can be done according to standards known to theskilled person in the art.

8. Mupirocin, Doxycycline or a Salt Thereof, and Ketoconazole

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin, a therapeutically effective amount of a doxycycline or apharmaceutically acceptable salt thereof, and a therapeuticallyeffective amount of a ketoconazole to make a homogenous compoundedcomposition. A disclosed compounded composition can comprise a drypowder formulation or can comprise an ointment.

In an aspect, a disclosed method can comprise obtaining the mupirocin,obtaining the doxycycline or a pharmaceutically acceptable salt thereof,obtaining the ketoconazole, or a combination thereof. In an aspect,obtaining can comprise obtaining a bulk source of the mupirocin,obtaining a bulk source of the doxycycline or a pharmaceuticallyacceptable salt thereof, obtaining a bulk source of the ketoconazole, ora combination thereof.

Mupirocin is known to the art and is discussed supra. Doxycycline aswell as pharmaceutically acceptable salts thereof are known to the artand are discussed supra. Ketoconazole is known to the art and isdiscussed supra.

In an aspect, a disclosed compounded composition comprising mupirocin,doxycycline or a salt thereof, and ketoconazole can comprise from about1.0% w/w to about 3.0% w/w mupirocin. In an aspect, a disclosedcompounded composition comprising mupirocin, doxycycline or a saltthereof, and ketoconazole can comprise about 1.6% w/w or about 1.8% w/wmupirocin. In an aspect, a disclosed compounded composition comprisingmupirocin, doxycycline or a salt thereof, and ketoconazole can comprisefrom about 1.5% to about 3.5% w/w or from about 4.0% to about 6.0% w/wdoxycycline or a pharmaceutically acceptable salt thereof. In an aspect,a disclosed compounded composition comprising mupirocin, doxycycline ora salt thereof, and ketoconazole can comprise about 2.5% w/w or 5.0% w/wdoxycycline or a pharmaceutically acceptable salt thereof. In an aspect,a disclosed compounded composition comprising mupirocin, doxycycline ora salt thereof, and ketoconazole can comprise from about 1.5% w/w toabout 3.5% w/w or from about 4.0% to about 6.0% w/w ketoconazole. In anaspect, a disclosed compounded composition comprising mupirocin,doxycycline or a salt thereof, and ketoconazole can comprise about 2.5%w/w or about 5.0% w/w ketoconazole.

In an aspect, a disclosed compounded composition comprising mupirocin,doxycycline or a salt thereof, and ketoconazole can comprise about 1.6%w/w mupirocin, about 5.0% w/w doxycycline or a pharmaceuticallyacceptable salt thereof, and about 5.0% w/w ketoconazole.

In an aspect, a disclosed compounded composition comprising mupirocin,doxycycline or a salt thereof, and ketoconazole can comprise about 1.8%w/w mupirocin, about 2.5% w/w doxycycline or a pharmaceuticallyacceptable salt thereof, and about 2.5% w/w ketoconazole.

In an aspect, the formula presented below can be used to identify theapproximate amount of powder from crushed doxycycline hyclate tabletsneeded for 1 g of the compounded composition: avg. tablet weight (g)×%of a tablet needed=amt. of powder from crushed tablets needed (g)

In an aspect, the average weight of a doxycycline hyclate tablet can beabout 0.2435 grams and can comprise about 100 mg of doxycycline. In anaspect, using the above-identified formula, the amount of powder fromcrushed doxycycline hyclate tablets needed for 1 g of the compoundedcomposition can be determined to be about 0.060875 g (or 60.875 mg).

${\underset{({0.2435\mspace{14mu} g})}{{average}\mspace{14mu}{tablet}\mspace{14mu}{weight}} \times \underset{({25.0\%})}{\%\mspace{14mu}{of}\mspace{14mu} a\mspace{14mu}{tablet}\mspace{14mu}{needed}}} = \underset{({0.060875\mspace{14mu} g})}{{amount}\mspace{14mu}{of}\mspace{14mu}{powder}\mspace{14mu}{from}\mspace{14mu}{crushed}\mspace{14mu}{tablets}\mspace{14mu}{needed}}$

In an aspect, using the above-identified formula, the amount of powderfrom crushed doxycycline hyclate tablets needed for 1 g of thecompounded composition can be determined to be about 0.12175 g (or121.75 mg).

${\underset{({0.2435\mspace{14mu} g})}{{average}\mspace{14mu}{tablet}\mspace{14mu}{weight}} \times \underset{({50.0\%})}{\%\mspace{14mu}{of}\mspace{14mu} a\mspace{14mu}{tablet}\mspace{14mu}{needed}}} = \underset{({0.12175\mspace{14mu} g})}{{amount}\mspace{14mu}{of}\mspace{14mu}{powder}\mspace{14mu}{from}\mspace{14mu}{crushed}\mspace{14mu}{tablets}\mspace{14mu}{needed}}$

In an aspect, the formula presented below can be used to identify theapproximate amount of powder from crushed ketoconazole tablets neededfor 1 g of the compounded composition: avg. tablet weight (g)×% of atablet needed=amt. of powder from crushed tablets needed (g)

In an aspect, the average weight of a ketoconazole tablet can be about0.310 grams and can comprise about 200 mg of ketoconazole. In an aspect,using the above-identified formula, the amount of powder from crushedketoconazole tablets needed for 1 g of the compounded composition can bedetermined to be about 0.0775 g (or 77.5 mg).

${\underset{({0.3100\mspace{14mu} g})}{{{avg}.\mspace{14mu}{tablet}}\mspace{14mu}{weight}\mspace{14mu}(g)} \times \underset{({25.0\%})}{\%\mspace{14mu}{of}\mspace{14mu} a\mspace{14mu}{tablet}\mspace{14mu}{needed}}} = \underset{({0.0775\mspace{14mu} g})}{{{amt}.\mspace{14mu}{of}}\mspace{14mu}{powder}\mspace{14mu}{from}\mspace{14mu}{crushed}\mspace{14mu}{tablets}\mspace{14mu}{needed}\mspace{14mu}(g)}$

In an aspect, using the above-identified formula, the amount of powderfrom crushed ketoconazole tablets needed for 1 g of the compoundedcomposition can be determined to be about 0.03875 g (or 38.75 mg).

${\underset{({0.3100\mspace{14mu} g})}{{{avg}.\mspace{14mu}{tablet}}\mspace{14mu}{weight}\mspace{14mu}(g)} \times \underset{({12.5\%})}{\%\mspace{14mu}{of}\mspace{14mu} a\mspace{14mu}{tablet}\mspace{14mu}{needed}}} = \underset{({0.03875\mspace{14mu} g})}{{{amt}.\mspace{14mu}{of}}\mspace{14mu}{powder}\mspace{14mu}{from}\mspace{14mu}{crushed}\mspace{14mu}{tablets}\mspace{14mu}{needed}\mspace{14mu}(g)}$

In an aspect, mupirocin can be added to a mixing container or extractedfrom a tube by attaching a key (e.g., a metal key) to an end of a tubeof mupirocin and sliding the key down the length of the tube towards theaperture of the tube, thereby forcing the contents of the tube into themixing container or out of the tube.

In an aspect, a disclosed method can comprise mixing one or moreexcipients or additives with the compounded composition. In an aspect,excipients or additives include, but are not limited to, the following:solvents, surfactants, humectants, preservatives, flavorings,stabilizers (including antioxidants), binders, and colorants.

In an aspect, a disclosed method can comprise mixing a therapeuticallyeffective amount of one or more additional anti-infective agents withthe compounded composition. In an aspect, the additional anti-infectiveagent can be an anti-bacterial agent. Anti-bacterial agents are known tothe art and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra. In an aspect, a disclosed method can compriseobtaining the additional anti-infective agent. In an aspect, obtainingcan comprise obtaining a bulk source of the anti-infective agent.

In an aspect, a disclosed method can comprise packaging the compoundedcomposition comprising mupirocin, doxycycline or a salt thereof, andketoconazole into a container and sealing the container. In an aspect, acontainer can be a container disclosed herein, such as, for example, aplastic tube, a glass or non-glass vial, a syringe, etc. In an aspect, adisclosed method can comprise sterilizing the compounded compositioncomprising mupirocin, doxycycline or a salt thereof, and ketoconazole.

In an aspect, the mixing can comprise using an electronic mortar andpestle (EMP). In an aspect, a disclosed method can comprise milling thehomogenous compounded composition (using, for example, a three-rollmill) Mixing and milling can be done according to standards known to theskilled person in the art. In an aspect, to make the compoundedcomposition, mupirocin, doxycycline or a pharmaceutically acceptablesalt thereof, and ketoconazole can be combined and mixed together using,for example, an electronic mortar and pestle (EMP). In an aspect, theEMP can be the Unguator 2100 or a similar device as recognized by theskilled person in the art. The compounded composition can be mixed atleast one time using the “normal” (or a comparable) setting. Then, thecompounded composition can be milled to achieve the desired consistencyusing, for example, a three-roll mill (e.g., an Exakt 120S-450). Themilled compounded composition can then be mixed again using, forexample, an EMP, and then distributed into one or more containers, suchas one or more containers disclosed herein (e.g., a plastic tube, aglass or non-glass vial, a syringe, etc.).

Example 8

In an aspect, to make 1 g of the compounded composition, which has about1.6% w/w mupirocin, about 5.0% w/w doxycycline or a pharmaceuticallyacceptable salt thereof, and about 5.0% w/w ketoconazole, about 0.8008 gof mupirocin 2.0% ointment, about 0.12175 g of powder from crusheddoxycycline hyclate tablets, and about 0.0775 g of powder from crushedketoconazole tablets can be combined and mixed together according to adisclosed method described above.

Table 8 provides the approximate amount of mupirocin, doxycyclinehyclate, and ketoconazole needed to make various amounts of thecompounded composition.

TABLE 8 MUPIROCIN, DOXYCYCLINE HYCLATE, AND KETOCONAZOLE CompoundedDoxycycline Hyclate Ketoconazole Composition Mupirocin (powder from(powder from (in grams) (2.0% ointment) crushed tablets) crushedtablets) 1 0.8008 g 0.12175 g  0.0775 g  4 3.2032 g 0.487 g 0.31 g 86.4064 g 0.974 g 0.62 g 25  20.02 g 3.04375 g  1.9375 g  50  40.04 g6.0875 g  3.875 g  240 192.192 g  29.22 g 18.6 g 1500 1201.2 g 182.625g  116.25 g 

As used in Example 8, the term “about” means a value falling within arange that is ±10% of the stated value. In an aspect, the skilled personcan combine 0.8008 g±10% mupirocin 2.0% ointment (e.g., from about0.72072 g-0.88088 g), 0.12175 g±10% powder from crushed doxycyclinehyclate tablets (e.g., from about 0.109575 g-0.133925 g), and 0.0775g±10% powder from crushed ketoconazole tablets (e.g., from about 0.06975g-0.08525 g) and mix together according to a method described above tomake about 1.0 g±10% of the compounded composition.

Example 9

In an aspect, to make 1 g of the compounded composition, which has about1.8% w/w mupirocin, about 2.5% w/w doxycycline or a pharmaceuticallyacceptable salt thereof, and about 2.5% w/w ketoconazole, about 0.9004 gof mupirocin 2.0% ointment, about 0.060875 g of powder from crusheddoxycycline hyclate tablets, and about 0.03875 g of powder from crushedketoconazole tablets can be combined and mixed together according to adisclosed method described above.

Table 9 provides the approximate amount of mupirocin, doxycyclinehyclate, and ketoconazole needed to make various amounts of thecompounded composition.

TABLE 9 MUPIROCIN, DOXYCYCLINE HYCLATE, AND KETOCONAZOLE CompoundedDoxycycline Hyclate Ketoconazole Composition Mupirocin (powder from(powder from (in grams) (2.0% ointment) crushed tablets) crushedtablets) 1 0.9004 g 0.060875 g   0.03875 g  4 3.6016 g 0.2435 g   0.155g 8 7.2032 g 0.487 g  0.31 g 25  22.51 g 1.521875 g   0.96875 g  50 45.02 g 3.04375 g  1.9375 g 240 216.096 g  14.61 g   9.3 g 1500 1350.6g 91.3125 g  58.125 g

As used in Example 9, the term “about” means a value falling within arange that is ±10% of the stated value. In an aspect, the skilled personcan combine 0.9004 g±10% mupirocin 2.0% ointment (e.g., from about0.81036 g-0.99044 g), 0.060875 g±10% powder from crushed doxycyclinehyclate tablets (e.g., from about 0.0547875 g-0.0669625 g), and 0.03875g±10% powder from crushed ketoconazole tablets (e.g., from about0.034875 g-0.042625 g) and mix together according to a method describedabove to make about 1.0 g±10% of the compounded composition.

9. Mupirocin, Tobramycin or a Salt Thereof, and Ketoconazole

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin, a therapeutically effective amount of tobramycin or apharmaceutically acceptable salt thereof, and a therapeuticallyeffective amount of ketoconazole to make a homogenous compoundedcomposition. A disclosed compounded composition can comprise a drypowder formulation or can comprise an ointment.

In an aspect, a disclosed method can comprise obtaining the mupirocin,obtaining the tobramycin or a pharmaceutically acceptable salt thereof,obtaining the ketoconazole, or a combination thereof. In an aspect,obtaining can comprise obtaining a bulk source of the mupirocin,obtaining a bulk source of the tobramycin or a pharmaceuticallyacceptable salt thereof, obtaining a bulk source of ketoconazole, or acombination thereof.

Mupirocin is known to the art and is discussed supra. Tobramycin as wellas pharmaceutically acceptable salts thereof are known to the art andare discussed supra. Ketoconazole is known to the art and is discussedsupra.

In an aspect, mupirocin can be added to a mixing container or extractedfrom a tube by attaching a key (e.g., a metal key) to an end of a tubeof mupirocin and sliding the key down the length of the tube towards theaperture of the tube, thereby forcing the contents of the tube into themixing container or out of the tube.

In an aspect, the average weight of a ketoconazole tablet can be about0.310 grams and can comprise about 200 mg of ketoconazole. In an aspect,the formula presented below can be used to identify the approximateamount of powder from crushed commercially available ketoconazoletablets needed for 1 g of the compounded composition:

${\underset{({0.3100\mspace{14mu} g})}{{{avg}.\mspace{14mu}{tablet}}\mspace{14mu}{weight}\mspace{14mu}(g)} \times \underset{({25.0\%})}{\%\mspace{14mu}{of}\mspace{14mu} a\mspace{14mu}{tablet}\mspace{14mu}{needed}}} = \underset{({0.0775\mspace{14mu} g})}{{{amt}.\mspace{14mu}{of}}\mspace{14mu}{powder}\mspace{14mu}{from}\mspace{14mu}{crushed}\mspace{14mu}{tablets}\mspace{14mu}{needed}\mspace{14mu}(g)}$

In an aspect, a disclosed compounded composition comprising mupirocin,tobramycin or a salt thereof, and ketoconazole can comprise from about1.4% w/w to about 2.0% w/w, from about 1.5% w/w to about 1.9% w/w, orfrom about 1.6% w/w to about 1.8% w/w mupirocin. In an aspect, adisclosed compounded composition comprising mupirocin, tobramycin or asalt thereof, and ketoconazole can comprise about 1.695% w/w or about1.8475% w/w mupirocin. In an aspect, a disclosed compounded compositioncomprising mupirocin, tobramycin or a salt thereof, and ketoconazole cancomprise from about 1.0% w/w to about 7.0% w/w or from about 2.0% w/w toabout 6.0% w/w tobramycin or a pharmaceutically acceptable salt thereof.In an aspect, a disclosed compounded composition comprising mupirocin,tobramycin or a salt thereof, and ketoconazole can comprise about 2.5%w/w or about 5.0% w/w tobramycin or a pharmaceutically acceptable saltthereof. In an aspect, a disclosed compounded composition comprisingmupirocin, tobramycin or a salt thereof, and ketoconazole can comprisefrom about 1.0% w/w to about 7.0% w/w or from about 2.0% w/w to about6.0% w/w ketoconazole. In an aspect, a disclosed compounded compositioncomprising mupirocin, tobramycin or a salt thereof, and ketoconazole cancomprise about 2.5% w/w or 5.0% w/w ketoconazole.

In an aspect, a disclosed compounded composition comprising mupirocin,tobramycin or a salt thereof, and ketoconazole can comprise from about1.695% w/w mupirocin, about 5.0% w/w tobramycin or a pharmaceuticallyacceptable salt thereof, and about 5.0% w/w ketoconazole.

In an aspect, a disclosed compounded composition comprising mupirocin,tobramycin or a salt thereof, and ketoconazole can comprise from about1.8475% w/w mupirocin, about 2.5% w/w tobramycin or a pharmaceuticallyacceptable salt thereof, and about 2.5% w/w ketoconazole.

In an aspect, a disclosed compounded composition comprising mupirocin,tobramycin or a salt thereof, and ketoconazole can comprise from about1.7% w/w to about 1.8% w/w mupirocin, about 5.0% w/w tobramycin or apharmaceutically acceptable salt thereof, and about 2.5% w/wketoconazole. In an aspect, a disclosed compounded compositioncomprising mupirocin, tobramycin or a salt thereof, and ketoconazole cancomprise about 1.749% w/w mupirocin, about 5.0% w/w tobramycin or apharmaceutically acceptable salt thereof, and about 2.5% w/wketoconazole. In an aspect, a disclosed compounded compositioncomprising mupirocin, tobramycin or a salt thereof, and ketoconazole cancomprise from about 1.7% w/w to about 1.8% w/w mupirocin, about 5.0% w/wtobramycin or a pharmaceutically acceptable salt thereof, and about 2.5%w/w ketoconazole. In an aspect, a disclosed compounded compositioncomprising mupirocin, tobramycin or a salt thereof, and ketoconazole cancomprise about 1.749% w/w mupirocin, about 5.0% w/w tobramycin or apharmaceutically acceptable salt thereof, and about 2.5% w/wketoconazole.

In an aspect, a disclosed method can comprise mixing one or moreexcipients or additives with the compounded composition. In an aspect,excipients or additives include, but are not limited to, the following:solvents, surfactants, humectants, preservatives, flavorings,stabilizers (including antioxidants), binders, and colorants.

In an aspect, a disclosed method can comprise mixing a therapeuticallyeffective amount of one or more additional anti-infective agents withthe compounded composition. In an aspect, the additional anti-infectiveagent can be an anti-bacterial agent. Anti-bacterial agents are known tothe art and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra. In an aspect, a disclosed method can compriseobtaining the additional anti-infective agent. In an aspect, obtainingcan comprise obtaining a bulk source of the anti-infective agent.

In an aspect, a disclosed method can comprise packaging the compoundedcomposition comprising mupirocin, tobramycin or a salt thereof, andketoconazole into a container and sealing the container. In an aspect, acontainer can be a container disclosed herein, such as, for example, asyringe. In an aspect, a disclosed method can comprise sterilizing thecompounded composition comprising mupirocin, tobramycin or a saltthereof, and ketoconazole.

In an aspect, the mixing can comprise using an electronic mortar andpestle (EMP). In an aspect, a disclosed method can comprise milling thehomogenous compounded composition (using, for example, a three-rollmill) Mixing and milling can be done according to standards known to theskilled person in the art. In an aspect, to make the compoundedcomposition, mupirocin, tobramycin or a pharmaceutically acceptable saltthereof, and ketoconazole can be combined and mixed together using, forexample, an electronic mortar and pestle (EMP). In an aspect, the EMPcan be the Unguator 2100 or a similar device as recognized by theskilled person in the art. The compounded composition can be mixed atleast one time using the “normal” (or a comparable) setting. Then, thecompounded composition can be milled to achieve the desired consistencyusing, for example, a three-roll mill (e.g., an Exakt 120S-450). Themilled compounded composition can then be mixed again using, forexample, an EMP, and then distributed into one or more containers, suchas one or more containers disclosed herein (e.g., a plastic tube, aglass or non-glass vial, a syringe, etc.).

Example 10

In an aspect, to make 1 g of the compounded composition, which has about1.8475% w/w mupirocin, about 2.5% w/w tobramycin or a pharmaceuticallyacceptable salt thereof, and about 2.5% w/w ketoconazole, about 0.92375g of mupirocin 2.0% ointment, about 0.0375 g of tobramycin sulfate forinjection USP powder, and about 0.03875 g of powder from crushedketoconazole tablets.

Table 10 provides the approximate amount of mupirocin, tobramycinsulfate, and ketoconazole needed to make various amounts of thecompounded composition.

TABLE 10 MUPIROCIN, TOBRAMYCIN SULFATE, AND KETOCONAZOLE CompoundedTobramycin Sulfate Ketoconazole Composition Mupirocin (USP powder(powder from (in grams) (2.0% ointment) for injection) crushed tablets)1 0.92375 g  0.0375 g  0.03875 g 4 3.695 g 0.15 g  0.155 g 8  7.39 g0.30 g   0.31 g 25 23.09375 g   0.9375 g  0.96875 g 50 46.1875 g  1.875g   1.9375 g 240 221.7 g  9.0 g   9.3 g 1500 1385.625 g   56.25 g  58.125 g

As used in Example 10, the term “about” means a value falling within arange that is ±10% of the stated value. In an aspect, the skilled personcan combine 0.92375 g±10% mupirocin 2.0% ointment (e.g., from about0.8313 g-1.0161 g), 0.0375 g±10% tobramycin sulfate USP powder forinjection (e.g., from about 0.03375 g-0.04125 g), and 0.03875 g±10%powder from crushed ketoconazole tablets (e.g., from about 0.03487g-0.04262 g) and mix together according to a method described above tomake about 1.0 g±10% of the compounded composition.

Example 11

In an aspect, to make about 1 g of the compounded composition, which hasabout 1.695% w/w mupirocin, about 5.0% w/w tobramycin or apharmaceutically acceptable salt thereof, and about 5.0% w/wketoconazole, about 0.8475 g of mupirocin 2.0% ointment, about 0.075 gof tobramycin sulfate for injection USP powder, and about 0.0775 g ofpowder from crushed ketoconazole tablets.

Table 11 provides the approximate amount of mupirocin, tobramycinsulfate, and ketoconazole needed to make various amounts of thecompounded composition.

TABLE 11 MUPIROCIN, TOBRAMYCIN SULFATE, AND KETOCONAZOLE CompoundedTobramycin Sulfate Ketoconazole Composition Mupirocin (USP powder(powder from (in grams) (2.0% ointment) for injection) crushed tablets)1 0.8475 g  0.075 g  0.0775 g  4 3.39 g 0.30 g 0.31 g 8 6.78 g 0.60 g0.62 g 25 21.1875 g   1.875 g  1.9375 g  50 42.375 g  3.75 g 3.875 g 240 203.4 g  18.0 g 18.6 g

As used in Example 11, the term “about” means a value falling within arange that is ±10% of the stated value. In an aspect, the skilled personcan combine 0.8475 g±10% mupirocin 2.0% ointment (e.g., from about0.7627 g-0.9322 g), 0.075 g±10% tobramycin sulfate USP powder forinjection (e.g., from about 0.0675 g-0.0825 g), and 0.0775 g±10% powderfrom crushed ketoconazole tablets (e.g., from about 0.06975 g-0.08525 g)and mix together according to a method described above to make about 1.0g±10% of the compounded composition.

10. Mupirocin, Ciprofloxacin or a Salt Thereof, and Ketoconazole

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin, a therapeutically effective amount of ciprofloxacin or apharmaceutically acceptable salt thereof, and a therapeuticallyeffective amount of ketoconazole to make a homogenous compoundedcomposition.

In an aspect, a disclosed method can comprise obtaining mupirocin,obtaining ciprofloxacin or a pharmaceutically acceptable salt thereof,obtaining ketoconazole, or a combination thereof. In an aspect,obtaining can comprise obtaining a bulk source of mupirocin, obtaining abulk source of ciprofloxacin or a pharmaceutically acceptable saltthereof, obtaining a bulk source of ketoconazole, or a combinationthereof.

Mupirocin is known to the art and is discussed supra. Ciprofloxacin aswell as pharmaceutically acceptable salts thereof are known to the artand are discussed supra. Ketoconazole is known to the art and isdiscussed supra.

In an aspect, a disclosed compounded composition comprising mupirocin,ciprofloxacin or a salt thereof, and ketoconazole can comprise fromabout 1.0% w/w to about 3.0% w/w, from about 1.5% w/w to about 2.5% w/w,from about 1.0% w/w to about 2.0% w/w, from about 1.5% w/w to about 2.0%w/w, or from about 2.0% w/w to about 2.5% w/w mupirocin. In an aspect, adisclosed compounded composition comprising mupirocin, ciprofloxacin ora salt thereof, and ketoconazole can comprise about 1.768% w/w or1.8453% w/w mupirocin. In an aspect, a disclosed compounded compositioncomprising mupirocin, ciprofloxacin or a salt thereof, and ketoconazolecan comprise from about 1.0% w/w to about 6.0% w/w, from about 1.5% w/wto about 5.0% w/w, from about 2.5% w/w to about 5.0% w/w, from about2.0% w/w to about 4.0% w/w, from about 2.0% w/w to about 4.0% w/w, orfrom about 2.5% w/w to about 3.0% w/w ciprofloxacin or apharmaceutically acceptable salt thereof. In an aspect, a disclosedcompounded composition comprising mupirocin, ciprofloxacin or a saltthereof, and ketoconazole can comprise about 2.5% w/w or about 5.0% w/wciprofloxacin or a pharmaceutically acceptable salt thereof. In anaspect, a disclosed compounded composition comprising mupirocin,ciprofloxacin or a salt thereof, and ketoconazole can comprise fromabout 1.0% w/w to about 6.0% w/w, from about 1.5% w/w to about 5.0% w/w,from about 2.5% w/w to about 5.0% w/w, from about 2.0% w/w to about 4.0%w/w, from about 2.0% w/w to about 4.0% w/w, or from about 2.5% w/w toabout 3.0% w/w ketoconazole. In an aspect, a disclosed compoundedcomposition comprising mupirocin, ciprofloxacin or a salt thereof, andketoconazole can comprise about 2.5% w/w or about 5.0% w/w ketoconazole.

In an aspect, a disclosed compounded composition can comprise about1.8453% w/w mupirocin, about 2.5% w/w ciprofloxacin or apharmaceutically acceptable salt thereof, and about 2.5% w/wketoconazole.

In an aspect, a disclosed compounded composition can comprise from about1.768% w/w mupirocin, about 5.0% w/w ciprofloxacin or a pharmaceuticallyacceptable salt thereof, and about 2.5% w/w ketoconazole.

In an aspect, the formula presented below can be used to identify theapproximate amount of powder from crushed commercially availableciprofloxacin tablets needed for 1 g of the compounded composition: avg.tablet weight (g)×% of a tablet needed=amt. of powder from crushedtablets needed (g)

In an aspect, the average weight of a ciprofloxacin tablet can be about1.158 grams and can comprise about 750 mg of ciprofloxacin.

${\underset{({1.158\mspace{14mu} g})}{{avg}\mspace{14mu}{tablet}\mspace{14mu}{weight}} \times \underset{({6.67\%})}{\%\mspace{14mu}{of}\mspace{14mu} a\mspace{14mu}{tablet}\mspace{14mu}{needed}}} = \underset{({0.07723\mspace{14mu} g})}{{amount}\mspace{14mu}{of}\mspace{14mu}{powder}\mspace{14mu}{from}\mspace{14mu}{crushed}\mspace{14mu}{tablets}\mspace{14mu}{needed}\mspace{14mu}(g)}$${\underset{({1.158\mspace{14mu} g})}{{avg}\mspace{14mu}{tablet}\mspace{14mu}{weight}} \times \underset{({3.33\%})}{\%\mspace{14mu}{of}\mspace{14mu} a\mspace{14mu}{tablet}\mspace{14mu}{needed}}} = \underset{({0.03856\mspace{14mu} g})}{{amount}\mspace{14mu}{of}\mspace{14mu}{powder}\mspace{14mu}{from}\mspace{14mu}{crushed}\mspace{14mu}{tablets}\mspace{14mu}{needed}\mspace{14mu}(g)}$

In an aspect, the formula presented below can be used to identify theapproximate amount of powder from crushed commercially availableketoconazole tablets needed for 1 g of the compounded composition: avg.tablet weight (g)×% of a tablet needed=amt. of powder from crushedtablets needed (g)

In an aspect, the average weight of a ketoconazole tablet can be about0.310 grams and can comprise about 200 mg of ketoconazole.

${\underset{({0.3100\mspace{14mu} g})}{{{avg}.\mspace{14mu}{tablet}}\mspace{14mu}{weight}\mspace{14mu}(g)} \times \underset{({12.5\%})}{\%\mspace{14mu}{of}\mspace{14mu} a\mspace{14mu}{tablet}\mspace{14mu}{needed}}} = \underset{({0.03875\mspace{14mu} g})}{{{amt}.\mspace{14mu}{of}}\mspace{14mu}{powder}\mspace{14mu}{from}\mspace{14mu}{crushed}\mspace{14mu}{tablets}\mspace{14mu}{needed}\mspace{14mu}(g)}$

In an aspect, mupirocin can be added to a mixing container or extractedfrom a tube by attaching a key (e.g., a metal key) to an end of a tubeof mupirocin and sliding the key down the length of the tube towards theaperture of the tube, thereby forcing the contents of the tube into themixing container or out of the tube.

In an aspect, a disclosed method can comprise mixing one or moreexcipients or additives with the compounded composition. In an aspect,excipients or additives include, but are not limited to, the following:solvents, surfactants, humectants, preservatives, flavorings,stabilizers (including antioxidants), binders, and colorants.

In an aspect, a disclosed method can comprise mixing a therapeuticallyeffective amount of one or more additional anti-infective agents withthe compounded composition. In an aspect, the additional anti-infectiveagent can be an anti-bacterial agent. Anti-bacterial agents are known tothe art and discussed supra. In an aspect, the additional anti-infectiveagent can be an anti-fungal agent. Anti-fungal agents are known to theart and discussed supra. In an aspect, a disclosed method can compriseobtaining the additional anti-infective agent. In an aspect, obtainingcan comprise obtaining a bulk source of the anti-infective agent.

In an aspect, a disclosed method can comprise packaging the compoundedcomposition comprising mupirocin, ciprofloxacin or a salt thereof, andketoconazole into a container and sealing the container. In an aspect, acontainer can be a container disclosed herein, such as, for example, aplastic tube, a glass or non-glass vial, a syringe, etc. In an aspect, adisclosed method can comprise sterilizing the compounded compositioncomprising mupirocin, ciprofloxacin or a salt thereof, and ketoconazole.

In an aspect, the mixing can comprise using an electronic mortar andpestle (EMP). In an aspect, a disclosed method can comprise milling thehomogenous compounded composition (using, for example, a three-rollmill) Mixing and milling can be done according to standards known to theskilled person in the art. Generally, to make the compoundedcomposition, mupirocin, ciprofloxacin or a salt thereof, andketoconazole can be combined and mixed together using, for example, anelectronic mortar and pestle (EMP). In an aspect, the EMP can be theUnguator 2100 or a similar device as recognized by the skilled person inthe art. The compounded composition can be mixed at least one time usingthe “normal” (or a comparable) setting. Then, the compounded compositioncan be milled to achieve the desired consistency using, for example, athree-roll mill (e.g., an Exakt 120S-450). The milled compoundedcomposition can then be mixed again using, for example, an EMP, and thendistributed into one or more containers, such as one or more containersdisclosed herein (e.g., a plastic tube, a glass or non-glass vial, asyringe, etc.).

Example 12

In an aspect, to make 1 g of the compounded composition, which has about1.8453% w/w mupirocin, about 2.5% w/w ciprofloxacin or apharmaceutically acceptable salt thereof, and about 2.5% w/wketoconazole, about 0.9227 g of mupirocin 2.0% ointment, about 0.03856 gof powder from crushed ciprofloxacin tablets, about 0.03875 mg of powderfrom crushed ketoconazole tablets can be combined and mixed togetheraccording to a disclosed method described above.

Table 12 provides the approximate amount of mupirocin, ciprofloxacin,and ketoconazole needed to make various amounts of the compoundedcomposition.

TABLE 12 MUPIROCIN, CIPROFLOXACIN OR A SALT THEREOF, AND KETOCONAZOLECompounded Ciprofloxacin Ketoconazole Composition Mupirocin (powder from(powder from (in grams) (2.0% ointment) crushed tablets) crushedtablets) 1 0.9227 g 0.03856 g  0.03875 g  4 3.6908 g 0.15424 g  0.155 g8 7.3816 g 0.30848 g  0.310 g 25 23.0675 g  0.964 g 0.96875 g  50 46.135g 1.928 g 1.9375 g  240 221.448 g  9.2544 g   9.3 g 1500 1384.05 g 57.84 g 58.125 g 

As used in Example 12, the term “about” means a value falling within arange that is ±10% of the stated value. In an aspect, the skilled personcan combine 0.9227 g±10% mupirocin 2.0% ointment (e.g., from about0.83043 g-1.01497 g), 0.03856 g±10% powder from crushed ciprofloxacintablets (e.g., from about 0.034704 g-0.042416 g), and 0.03875 g±10%powder from crushed ketoconazole tablets (e.g., from about 0.034875g-0.042625 g) and mix together according to a method described above tomake about 1.0 g±10% of the compounded composition.

Example 13

In an aspect, to make 1 g of the compounded composition, which has about1.768% w/w mupirocin, about 5.0% w/w ciprofloxacin or a pharmaceuticallyacceptable salt thereof, and about 2.5% w/w ketoconazole, 0.8841 g ofmupirocin 2% ointment, about 0.07723 g of powder from crushedciprofloxacin tablets, and about 0.03875 g of powder from crushedketoconazole tablets (about 12.5% of a crushed 200 mg ketoconazoletablet) can be combined and mixed together according to a disclosedmethod described above.

Table 13 provides the approximate amount of mupirocin, ciprofloxacin,and ketoconazole powder needed to make various amounts of the compoundedcomposition.

TABLE 13 MUPIROCIN, CIPROFLOXACIN OR A SALT THEREOF, AND KETOCONAZOLECompounded Ciprofloxacin Ketoconazole Composition Mupirocin (powder from(powder from (in grams) (2.0% ointment) crushed tablets) crushedtablets) 1 0.8841 g 0.07723 g 0.03875 g 4 3.5364 g 0.30892 g  0.155 g 87.0728 g 0.61784 g   0.31 g 25 22.1025 g  1.93075 g 0.96875 g 50 44.205g  3.8615 g  1.9375 g 240 212.184 g  18.5352 g   9.3 g 1500 1326.15 g 115.845 g  58.125 g

As used in Example 13, the term “about” means a value falling within arange that is ±10% of the stated value. In an aspect, the skilled personcan combine 0.8841 g±10% mupirocin 2.0% ointment (e.g., from about0.79569 g-0.97251 g), 0.07723 g±10% powder from crushed ciprofloxacintablets (e.g., from about 0.069507 g-0.084953 g), and 0.03875 g±10%powder from crushed ketoconazole tablets (e.g., from about 0.034875g-0.042625 g) and mix together according to a method described above tomake about 1.0 g±10% of the compounded composition.

11. Mupirocin and/or Nystatin

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin and a therapeutically effective amount of nystatin with anexcipient base powder comprising a blend of micronized xylitol andpoloxamers to make a homogenous compounded composition.

In an aspect, the compounded composition can be a dry powderformulation.

In an aspect, the mupirocin can be a dry powder. The mupirocin can bepure or substantially pure. In an aspect, the mupirocin can be anointment. In an aspect, the mupirocin can be a 2% ointment. In anaspect, the nystatin can be a dry powder. In an aspect, the nystatin canbe an ointment. The nystatin can be pure or substantially pure.

In an aspect, the method can comprise obtaining the mupirocin, thenystatin, the excipient base powder, or a combination thereof. In anaspect, obtaining the mupirocin, the nystatin, or the excipient basepowder can comprise obtaining a bulk source of the mupirocin, a bulksource of the nystatin, a bulk source of the excipient base powder, orobtaining a combination thereof.

In an aspect, the excipient base powder can comprise Loxasperse™excipient base powder. In an aspect, the excipient base powder cancomprise Loxasperse™ excipient base powder and XyliFos™ excipient basepowder.

In an aspect, the mupirocin can comprise from about 10% to about 40% w/wof the compounded composition. In an aspect, the mupirocin can comprisefrom about 15% to about 35% w/w of the compounded composition. In anaspect, the mupirocin can comprise from about 20% to about 30% w/w ofthe compounded composition. In an aspect, the mupirocin can compriseabout 25% w/w of the compounded composition.

In an aspect, the nystatin can comprise from about 10% to about 40% w/wof the compounded composition. In an aspect, the nystatin can comprisefrom about 15% to about 35% w/w of the compounded composition. In anaspect, the nystatin can comprise from about 20% to about 30% w/w of thecompounded composition. In an aspect, the nystatin can comprise about25% w/w of the compounded composition.

In an aspect, the ratio of the mupirocin to the nystatin in thecompounded composition can be from about 1:4 to about 4:1. In an aspect,the ratio of the mupirocin the nystatin can be about 1:1. In an aspect,the ratio of the mupirocin to the nystatin can be about 1.25:1.

In an aspect, the method can comprise mixing a therapeutically effectiveamount of an additional anti-infective agent with the compoundedcomposition. In an aspect, the additional anti-infective agent can be adry powder. In an aspect, the additional anti-infective agent can be anointment. The additional anti-infective agent can be pure orsubstantially pure. The additional anti-infective agent can be obtainedfrom a bulk source.

In an aspect, the additional anti-infective agent can be ananti-bacterial agent. Anti-bacterial agents are known to the art anddiscussed supra. In an aspect, the additional anti-infective agent canbe an anti-fungal agent. Anti-fungal agents are known to the art anddiscussed supra. In an aspect, the method can comprise obtaining theadditional anti-infective agent. In an aspect, obtaining the additionalanti-infective agent can comprise obtaining a bulk source of theanti-infective agent.

In an aspect, the method can comprise packaging the compoundedcomposition into a container and sealing the container. In an aspect,the method can comprise sterilizing the container comprising thecompounded composition comprising mupirocin and nystatin.

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount ofmupirocin and a therapeutically effective amount of an anti-fungal agentwith an excipient base powder comprising a blend of micronized xylitoland poloxamers to make a homogenous compounded composition.

Disclosed herein is a method of making a compounded composition, themethod comprising: mixing a therapeutically effective amount of ananti-bacterial agent and a therapeutically effective amount of nystatinwith an excipient base powder comprising a blend of micronized xylitoland poloxamers to make a homogenous compounded composition.

F. Methods of Treating or Preventing an Infection Using a CompoundedComposition

Disclosed herein is a method of treating or preventing an infectionusing any compounded composition herein.

In one aspect the method comprises (i) adding a compounded compositionto water contained within a footbath; (ii) agitating the water containedwithin the footbath; and (iii) contacting the agitated water with atleast a part of one or both feet of a subject.

Disclosed herein is a method of treating or preventing a foot infectionusing any compounded composition herein.

In one aspect, the method comprises: (i) agitating water containedwithin a footbath; (ii) adding a compounded composition to the watercontained with the footbath; and (iii) contacting the agitated waterwith at least a part of one or both feet of a subject.

In another aspect, the method comprises: (i) mixing a compoundedcomposition with a diluent to create a solution; (ii) adding thesolution to water contained within a footbath; (iii) agitating the watercontained within the footbath; and (iv) contacting the agitated waterwith at least part of one or both feet of a subject.

In another aspect, the method comprises: (i) adding a compoundedcomposition comprising an anti-bacterial agent and an anti-fungal agentto water contained within a footbath; (ii) agitating the water containedwithin the footbath; and (iii) contacting the agitated water with atleast a part of one or both feet of a subject.

In an aspect, the method can comprise adding a diluent to the watercontained in the footbath. In an aspect, the diluent can comprise sodiumhypochlorite. In an aspect, the diluent can comprise Dakin's solution.In an aspect, the amount of diluent can be about 3.75 mL to about 60 mL.In an aspect, the amount of diluent can be about 15 mL.

In an aspect, the subject has been diagnosed with or is suspected ofhaving a bacterial infection that affects at least part of one or bothfeet. In an aspect, the subject has been diagnosed with or is suspectedof having a fungal infection that affects at least part of one or bothfeet. In an aspect, the subject has been diagnosed with or is suspectedof having a bacterial infection and a fungal infection that affect atleast part of one or both feet.

In an aspect, the subject can have diabetes. In an aspect, the subjectcan be obese. In an aspect, the subject can have poor blood flow. In anaspect, the subject can routinely wear thick socks. In an aspect, thesubject can routinely wear heavy boots.

In an aspect, contacting can comprise placing at least part of one orboth feet of the subject in the footbath. In an aspect, contacting cancomprise placing at least part of one or both feet of the subject in thefootbath for about 5 to about 15 minutes. In an aspect, contacting cancomprise placing at least part of one or both feet of the subject in thefootbath for about 10 minutes.

In an aspect, the method can comprise repeating steps (i)-(iii) or(i)-(iv) daily. In an aspect, the method can comprise repeating steps(i)-(iii) or (i)-(iv) daily until the bacterial infection or suspectedbacterial infection can be eradicated. In an aspect, the method cancomprise repeating steps (i)-(iii) or (i)-(iv) daily until the fungalinfection or suspected fungal infection can be eradicated. In an aspect,the method can comprise repeating steps (i)-(iii) or (i)-(iv) dailyuntil the infection or the suspected infection can be eradicated.

In an aspect, the method can comprise heating the water contained withinthe footbath. In an aspect, a footbath can comprise a mechanicalagitation agent to mechanically agitate the enclosed water, a heatingagent to heat the enclosed water, or both. Mechanical agitation agentsand/or means to agitate water within a compartment are known to the art.In an aspect, a mechanical agitation agent can be a motorized agitationagent. In an aspect, an agitation agent or an agitator can be coupled toboth a motor and the footbath. Motors and agitators are known to theart. In an aspect, mechanical agitation can serve to distribute thecompounded composition throughout the water contained within thefootbath. Heating agents and/or means to heat water in a compartment areknown to the art.

In an aspect, a disclosed compounded composition comprising ananti-bacterial agent and an anti-fungal agent can be encapsulated in oneor more capsules or be in the form of an ointment in a tube or syringe.In an aspect, the one or more capsules or tubes comprising thecompounded composition can be added to the water contained within thefootbath. In an aspect, the one or more capsules or tubes candisintegrate and the compounded composition can be dissolved in thewater contained within the footbath. In an aspect, a subject can open orbreak apart the one or more capsule and pour the contents of the openedor broken capsules or inject the ointment into the water containedwithin a footbath.

In an aspect, a method of treating an infection using the compoundedcomposition and a footbath may include adding the compounded compositionand a diluent to a footbath and contacting a foot of the subject withthe combined solution according to any method herein. In one example,diluent may be added to a mixing container and combined with thecompounded composition, which may comprise a powder or ointment andwhich may be in one or more capsules or tubes. For example, thecompounded composition may comprise a compounded ointment and beprovided in a syringe. The contents of the mixing container may be mixedand added to a footbath. The footbath may be allowed to agitate. Thesubject may contact the agitating solution for a suitable amount oftime, e.g., 10 minutes or so. The treatment may be repeated once or moredaily as required.

In an aspect, treating an infection includes formulating a treatmentsolution comprising combining a commercially available clindamycinsolution with a diluent, such as any diluent described herein, in amixing container or footbath. The treatment solution, if in a mixingcontainer, may be added to the footbath. Similarly, the diluent may beadded to the footbath prior to or after the clindamycin solution. In oneexample, the clindamycin solution comprises a 1% clindamycin solution.Treating a foot infection in a footbath may comprise combining a 30 mLor 60 mL 1% clindamycin solution with diluent. The affected area of thefoot may be placed in the footbath or otherwise contacted with thetreatment solution in the footbath for a suitable amount of time, e.g.,10 minutes or so. The treatment may be repeated once or more daily asrequired.

In an aspect, treating an infection includes formulating treatmentsolution comprising combining a commercially available erythromycinsolution with a diluent, such as any diluent described herein, in amixing container or footbath. The treatment solution, if in a mixingcontainer, may be added to the footbath. Similarly, the diluent may beadded to the footbath prior to or after the erythromycin solution. Inone example, the erythromycin solution comprises a 2% erythromycinsolution. Treating a foot infection in a footbath may comprise combininga 30 mL or 60 mL 2% erythromycin solution with diluent. The affectedarea of the foot may be placed in the footbath or otherwise contactedwith the treatment solution in the footbath for a suitable amount oftime, e.g., 10 minutes or so. The treatment may be repeated once or moredaily as required.

In an aspect, one or both of clindamycin solution or erythromycinsolution may be used together with or replace an antibacterial active inany of the compounded compositions herein in a footbath. Similarly, insome embodiments, clindamycin solution or erythromycin solution may beused in a combination treatment regime with any of the compoundedcompositions herein in a footbath. For example, a foot of a subject maybe treated with a treatment solution in a footbath comprising anycompounded composition and diluent described herein and separately,before or after, be treated with a treatment solution in a footbathcomprising one or more of clindamycin solution or erythromycin solutionin diluent, as described herein. The consecutive treatments may beadministered daily, over two days, or as otherwise necessary.

G. Methods of Treating or Preventing an Infection Using Anti-InfectiveAgents

Disclosed herein is a method of treating or preventing an infection, themethod comprising: (i) adding one or more powders to water containedwithin a footbath; (ii) agitating the water contained within thefootbath; and (iii) contacting the agitated water with at least a partof one or both feet of a subject.

2. Anti-Bacterial Agent and/or Anti-Fungal Agent

Disclosed herein is a method of treating or preventing an infection, themethod comprising: (i) adding an anti-bacterial agent to water containedwithin a footbath; (ii) adding an anti-fungal agent to the water, (iii)agitating the water contained within the footbath; and (iv) contactingthe agitated water with at least a part of one or both feet of asubject.

In an aspect, the anti-bacterial agent be a dry powder. In an aspect,the antibacterial agent can be an ointment. In an aspect, theanti-bacterial agent can be obtained from a bulk source. Theanti-bacterial agent can be pure or substantially pure.

In an aspect, the anti-fungal agent be a dry powder. In an aspect, theanti-fungal agent can be an ointment. In an aspect, the anti-fungalagent can be obtained from a bulk source. The anti-fungal agent can bepure or substantially pure.

In an aspect, the anti-bacterial agent can comprise afenide, amikacin,amoxicillin, ampicillin, arsphenamine, azithromycin, azlocillin,aztreonam, bacampicillin, bacitracin, carbacephem (loracarbef),carbenicillin, cefaclor, cefadroxil, cefalotin, cefamandole, cefazolin,cefdinir, cefditoren, cefepime, cefixime, cefoperazone, cefotaxime,cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, ceftizoxime,ceftobiprole, ceftriaxone, cefuroxime, cephalexin, chloramphenicol,chlorhexidine, ciprofloxacin, clarithromycin, clavulanic acid,clindamycin, cloxacillin, colimycin, colistimethate teicoplanin,colistin, demeclocycline, dicloxacillin, dirithromycin, doripenem,doxycycline, efprozil, enoxacin, ertapenem, erythromycin, ethambutol,flucloxacillin, fosfomycin, furazolidone, gatifloxacin, geldanamycin,gentamicin, grepafloxacin, herbimycin, imipenem, isoniazid, kanamycin,levofloxacin, lincomycin, linezolid, lomefloxacin, meropenem,meticillin, metronidazole, mezlocillin, minocycline, mitomycin,moxifloxacin, mupirocin, nafcillin, neomycin, netilmicin,nitrofurantoin, norfloxacin, ofloxacin, oxacillin, oxytetracycline,paromomycin, penicillin G, penicillin V, piperacillin, pivmecillinam,platensimycin, polymyxin B, prontosil, pvampicillin, pyrazinamide,quinupristin/dalfopristin, rifampicin, rifampin, roxithromycin,sparfloxacin, spectinomycin, spiramycin, sulbactam, sulfacetamide,sulfamethizole, sulfamethoxazole, sulfanilimide, sulfisoxazole,sulphonamides, sultamicillin, telithromycin, tetracycline,thiamphenicol, ticarcillin, tobramycin, trimethoprim,trimethoprim-sulfamethoxazole, troleandomycin, trovafloxacin, or acombination thereof.

In an aspect of a disclosed method, the anti-bacterial agent cancomprise mupirocin.

In an aspect of a disclosed method, the anti-bacterial agent cancomprise azithromycin.

In an aspect, the anti-fungal agent can comprise abafungin,albaconazole, amorolfin, amphotericin b, anidulafungin, bifonazole,butenafine, butoconazole, candicidin, caspofungin, ciclopirox,clotrimazole, econazole, fenticonazole, filipin, fluconazole,flucytosine, griseofulvin, haloprogin, hamycin, isavuconazole,isoconazole, itraconazole, ketoconazole, micafungin, miconazole,naftifine, natamycin, nystatin, omoconazole, oxiconazole, polygodial,posaconazole, ravuconazole, rimocidin, sertaconazole, sulconazole,terbinafine, terconazole, tioconazole, tolnaftate, undecylenic acid,voriconazole, or a combination thereof.

In an aspect of a disclosed method, the anti-fungal agent can comprisefluconazole. In an aspect of a disclosed method, the anti-fungal agentcan comprise itraconazole. In an aspect of a disclosed method, theanti-fungal agent can comprise nystatin.

In an aspect, a disclosed method can treat or prevent an infectionaffecting the skin of at least a portion of a subject's foot or feet. Inan aspect, a disclosed method can treat or prevent an infectionaffecting the nail of at least one toe on a subject's foot or feet.

Disclosed herein a method of treating or preventing an infection, themethod comprising: (i) mixing an anti-bacterial agent, an anti-fungalagent, and a diluent to form a solution; (ii) adding the solution towater contained within a footbath; (iii) agitating the water containedwithin the footbath; and (iv) contacting the agitated water with atleast part of one or both feet of a subject.

In an aspect, the anti-bacterial agent, the anti-fungal agent, and thediluent can be mixed in a mixing container. In an aspect, a mixingcontainer can have a pre-determined size that can measure or hold apre-determined amount or volume. For example, in an aspect, a mixingcontainer can measure or hold an amount of about 1 ounces to about 30ounces. In an aspect, the mixing container can hold about 6 ounces. Inan aspect, the mixing container can hold about 16 ounces.

In an aspect, the anti-bacterial agent be a dry powder. In an aspect,the antibacterial agent can be an ointment. In an aspect, theanti-bacterial agent can be obtained from a bulk source. Theanti-bacterial agent can be pure or substantially pure.

In an aspect, the anti-fungal agent be a dry powder. In an aspect, theanti-fungal agent can be an ointment. In an aspect, the anti-fungalagent can be obtained from a bulk source. The anti-fungal agent can bepure or substantially pure.

In an aspect, the anti-bacterial agent can comprise afenide, amikacin,amoxicillin, ampicillin, arsphenamine, azithromycin, azlocillin,aztreonam, bacampicillin, bacitracin, carbacephem (loracarbef),carbenicillin, cefaclor, cefadroxil, cefalotin, cefamandole, cefazolin,cefdinir, cefditoren, cefepime, cefixime, cefoperazone, cefotaxime,cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, ceftizoxime,ceftobiprole, ceftriaxone, cefuroxime, cephalexin, chloramphenicol,chlorhexidine, ciprofloxacin, clarithromycin, clavulanic acid,clindamycin, cloxacillin, colimycin, colistimethate teicoplanin,colistin, demeclocycline, dicloxacillin, dirithromycin, doripenem,doxycycline, efprozil, enoxacin, ertapenem, erythromycin, ethambutol,flucloxacillin, fosfomycin, furazolidone, gatifloxacin, geldanamycin,gentamicin, grepafloxacin, herbimycin, imipenem, isoniazid, kanamycin,levofloxacin, lincomycin, linezolid, lomefloxacin, meropenem,meticillin, metronidazole, mezlocillin, minocycline, mitomycin,moxifloxacin, mupirocin, nafcillin, neomycin, netilmicin,nitrofurantoin, norfloxacin, ofloxacin, oxacillin, oxytetracycline,paromomycin, penicillin G, penicillin V, piperacillin, pivmecillinam,platensimycin, polymyxin B, prontosil, pvampicillin, pyrazinamide,quinupristin/dalfopristin, rifampicin, rifampin, roxithromycin,sparfloxacin, spectinomycin, spiramycin, sulbactam, sulfacetamide,sulfamethizole, sulfamethoxazole, sulfanilimide, sulfisoxazole,sulphonamides, sultamicillin, telithromycin, tetracycline,thiamphenicol, ticarcillin, tobramycin, trimethoprim,trimethoprim-sulfamethoxazole, troleandomycin, trovafloxacin, or acombination thereof.

In an aspect, the anti-fungal agent can comprise abafungin,albaconazole, amorolfin, amphotericin b, anidulafungin, bifonazole,butenafine, butoconazole, candicidin, caspofungin, ciclopirox,clotrimazole, econazole, fenticonazole, filipin, fluconazole,flucytosine, griseofulvin, haloprogin, hamycin, isavuconazole,isoconazole, itraconazole, ketoconazole, micafungin, miconazole,naftifine, natamycin, nystatin, omoconazole, oxiconazole, polygodial,posaconazole, ravuconazole, rimocidin, sertaconazole, sulconazole,terbinafine, terconazole, tioconazole, tolnaftate, undecylenic acid,voriconazole, or a combination thereof.

In an aspect, the amount of the anti-bacterial agent added to thediluent compared to the amount of the anti-fungal agent added to thediluent can be from about 1:4 to about 4:1. In an aspect, the ratio canbe about 1:1. In an aspect, the ratio of the anti-bacterial agent to theanti-fungal agent be about 1.25:1. See, e.g., Table 1.

In an aspect, the amount of the anti-bacterial agent can be from about125 mg to about 2000 mg. In an aspect, the amount of the anti-fungalagent can be from about 125 mg to about 2000 mg. In an aspect of adisclosed method, the amount of the anti-bacterial agent can be about250 mg and the amount of the anti-fungal agent can be about 250 mg. Inan aspect of a disclosed method, the amount of the anti-bacterial agentca be about 250 mg and the amount of the anti-fungal agent can be about500 mg. In an aspect of a disclosed method, the amount of theanti-bacterial agent can be about 500 mg and the amount of theanti-fungal agent can be about 500 mg. In an aspect of a disclosedmethod, the amount of the anti-bacterial agent can be about 1000 mg andthe amount of the anti-fungal agent can be about 500 mg.

In an aspect, the diluent can comprise sodium hypochlorite. In anaspect, the diluent can comprise Dakin's solution. In an aspect, theamount of diluent can be about 3.75 mL to about 60 mL. In an aspect, theamount of diluent can be about 15 mL.

In an aspect, the subject has been diagnosed with or is suspected ofhaving a bacterial infection that affects at least part of one or bothfeet. In an aspect, the subject has been diagnosed with or is suspectedof having a fungal infection that affects at least part of one or bothfeet. In an aspect, the subject has been diagnosed with or is suspectedof having a bacterial infection and a fungal infection that affect atleast part of one or both feet.

In an aspect, the subject can have diabetes. In an aspect, the subjectcan be obese. In an aspect, the subject can have poor blood flow. In anaspect, the subject can routinely wear thick socks. In an aspect, thesubject can routinely wear heavy boots.

In an aspect, contacting can comprise placing at least part of one orboth feet of the subject in the footbath. In an aspect, contacting cancomprise placing at least part of one or both feet of the subject in thefootbath for about 5 to about 15 minutes. In an aspect, contacting cancomprise placing at least part of one or both feet of the subject in thefootbath for about 10 minutes.

In an aspect, the method can comprise repeating steps (i)-(iv) daily. Inan aspect, the method can comprise repeating steps (i)-(iv) daily untilthe bacterial infection or suspected bacterial infection can beeradicated. In an aspect, the method can comprise repeating steps(i)-(iv) daily until the fungal infection or suspected fungal infectioncan be eradicated. In an aspect, the method can comprise repeating steps(i)-(iv) daily until the infection or the suspected infection can beeradicated.

In an aspect, the method can comprise heating the water contained withinthe footbath.

In an aspect, a footbath can comprise a mechanical agitation agent tomechanically agitate the enclosed water, a heating agent to heat theenclosed water, or both. Mechanical agitation agents and/or means toagitate water within a compartment are known to the art. In an aspect, amechanical agitation agent can be a motorized agitation agent. In anaspect, an agitation agent or an agitator can be coupled to both a motorand the footbath. Motors and agitators are known to the art. In anaspect, mechanical agitation can serve to distribute the solutionthroughout the water contained within the footbath. Heating agentsand/or means to heat water in a compartment are known to the art.

In an aspect, the method can comprise adding to the diluent or to thewater an excipient base powder comprising a blend of micronized xylitoland poloxamers. In an aspect, the excipient base powder can compriseLoxasperse™ excipient base powder. In an aspect, the excipient basepowder can comprise Loxasperse™ excipient base powder and XyliFos™excipient base powder. In an aspect, an excipient base powder can beobtained from a bulk source.

In an aspect, the method can comprise orally administering to thesubject a pharmaceutical composition comprising an anti-bacterial agent.Anti-bacterial agents are known to the art and discussed supra. In anaspect, the method can comprise orally administering to the subject apharmaceutical composition comprising an anti-fungal agent. Anti-fungalagents are known to the art and discussed supra. In an aspect, themethod can comprise orally administering to the subject a pharmaceuticalcomposition comprising an anti-bacterial agent and a pharmaceuticalcomposition comprising an anti-fungal agent.

In an aspect, the method can comprise adding to the diluent or to thewater one or more additional anti-infective agents. In an aspect, theadditional anti-infective agent can be a dry powder. In an aspect, theadditional anti-infective agent can be an ointment. The additionalanti-infective agent can be pure or substantially pure. The additionalanti-infective agent can be obtained from a bulk source. In an aspect,the additional anti-infective agent can be an anti-bacterial agent.Anti-bacterial agents are known to the art and discussed supra. In anaspect, the additional anti-infective agent can be an anti-fungal agent.Anti-fungal agents are known to the art and discussed supra.

In an aspect, a disclosed anti-bacterial agent can be encapsulated inone or more capsules. In an aspect, the one or more capsules comprisingthe anti-bacterial agent can be added to the diluent. In an aspect, theone or more capsules can diluent. In an aspect, a subject can open orbreak apart the one or more capsule and pour the contents of the openedor broken capsules into the diluent.

In an aspect, a disclosed an anti-fungal agent can be encapsulated inone or more capsules. In an aspect, the one or more capsules comprisingthe anti-fungal agent can be added to the diluent. In an aspect, the oneor more capsules can disintegrate and the anti-fungal can be dissolvedin the diluent. In an aspect, a subject can open or break apart the oneor more capsule and pour the contents of the opened or broken capsulesinto the diluent.

In an aspect, a disclosed method can comprise emptying the water fromthe footbath. In an aspect, a disclosed method can comprise cleaning thefootbath. In an aspect, a disclosed method can comprise drying thefootbath.

In an aspect, a disclosed method can treat or prevent an infectionaffecting the skin of at least a portion of a subject's foot or feet. Inan aspect, a disclosed method can treat or prevent an infectionaffecting the nail of at least one toe on a subject's foot or feet.

What is claimed is:
 1. A method of treating or preventing a footbacterial infection of a subject, the method comprising: formulating anaqueous topical footbath treatment solution comprising combininglevofloxacin oral solution and an aqueous diluent, wherein the footbathtreatment solution comprises artificial flavor, propylene glycol, water,saccharin sodium, sucrose, and glycerin; and topically administering thefootbath treatment solution to skin of a foot of the subject bysubmerging the skin in the footbath treatment solution within a bathingcontainer.
 2. The method of claim 1, wherein combining the levofloxacinoral solution and the aqueous diluent comprises combining levofloxacinoral solution, 125 mg/5 mL (25 mg/mL), and the aqueous diluent.
 3. Themethod of claim 1, wherein combining the levofloxacin oral solution andthe aqueous diluent comprises combining about 10 mL to about 30 mLlevofloxacin oral solution, 125 mg/5 mL (25 mg/mL), and the aqueousdiluent.
 4. The method of claim 1, wherein combining the levofloxacinoral solution and the aqueous diluent comprises combining about 10 mL toabout 40 mL levofloxacin oral solution, 125 mg/5 mL (25 mg/mL), andabout 0.5 L to about 4 L of the aqueous diluent.
 5. The method of claim1, wherein combining the levofloxacin oral solution and the aqueousdiluent comprises combining about 10 mL to about 30 mL levofloxacin oralsolution, 125 mg/5 mL (25 mg/mL), and about 1 L to about 2 L of theaqueous diluent.
 6. The method of claim 5, wherein the aqueous diluentcomprises sodium hypochlorite.
 7. The method of claim 5, furthercomprising agitating the footbath treatment solution within the bathingcontainer during the administering.
 8. The method of claim 5, furthercomprising heating the footbath treatment solution within the bathingcontainer.
 9. The method of claim 5, wherein the aqueous diluent iswater or a saline solution.